# Official Journal L 117/2007

| | ISSN 1725-2555 |
| --- | --- |
| Official Journal
  of the European Union | L 117 |
| | |
| English edition | Legislation | Volume 505 May 2007 |

ISSN 1725-2555

Official Journal

of the European Union

L 117

English edition

Legislation

Volume 505 May 2007

---

| Contents | | I   Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | | Commission Regulation (EC) No 493/2007 of 4 May 2007 establishing the standard import values for determining the entry price of certain fruit and vegetables | 1 |
| | | Commission Regulation (EC) No 494/2007 of 4 May 2007 amending Regulation (EC) No 486/2007 fixing the import duties in the cereals sector applicable from 1 May 2007 | 3 |
| | * | Commission Regulation (EC) No 495/2007 of 4 May 2007 amending Regulation (EEC) No 3077/78 on the equivalence with Community certificates of attestations accompanying hops imported from non-member countries | 6 |
| | * | Commission Regulation (EC) No 496/2007 of 4 May 2007 amending Regulation (EC) No 600/2005 as regards the introduction of a maximum residue limit for the feed additive Salinomax 120G, belonging to the group of coccidiostats and other medicinal substances (
  1
  ) | 9 |
| | * | Commission Regulation (EC) No 497/2007 of 4 May 2007 concerning the authorisation of endo-1,4-beta-xylanase EC 3.2.1.8 (Safizym X) as a feed additive (
  1
  ) | 11 |

Contents

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

page

REGULATIONS

Commission Regulation (EC) No 493/2007 of 4 May 2007 establishing the standard import values for determining the entry price of certain fruit and vegetables

1

Commission Regulation (EC) No 494/2007 of 4 May 2007 amending Regulation (EC) No 486/2007 fixing the import duties in the cereals sector applicable from 1 May 2007

3

*

Commission Regulation (EC) No 495/2007 of 4 May 2007 amending Regulation (EEC) No 3077/78 on the equivalence with Community certificates of attestations accompanying hops imported from non-member countries

6

*

Commission Regulation (EC) No 496/2007 of 4 May 2007 amending Regulation (EC) No 600/2005 as regards the introduction of a maximum residue limit for the feed additive Salinomax 120G, belonging to the group of coccidiostats and other medicinal substances (
  1
  )

1

9

*

Commission Regulation (EC) No 497/2007 of 4 May 2007 concerning the authorisation of endo-1,4-beta-xylanase EC 3.2.1.8 (Safizym X) as a feed additive (
  1
  )

1

11

| | | II   Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory |
| --- | --- | --- |
| | | DECISIONS |
| | | Commission |
| | | 2007/304/EC |
| | * | Commission Decision of 25 April 2007 on the withdrawal from the market of Bt176 (SYN-EV176-9) maize and its derived products
  (notified under document number C(2007) 1804) | 14 |
| | | 2007/305/EC |
| | * | Commission Decision of 25 April 2007 on the withdrawal from the market of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape and its derived products
  (notified under document number C(2007) 1805) | 17 |
| | | 2007/306/EC |
| | * | Commission Decision of 25 April 2007 on the withdrawal from the market of Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and its derived products
  (notified under document number C(2007) 1806) | 20 |
| | | 2007/307/EC |
| | * | Commission Decision of 25 April 2007 on the withdrawal from the market of Topas 19/2 (ACS-BNØØ7-1) oilseed rape and its derived products
  (notified under document number C(2007) 1809) | 23 |
| | | 2007/308/EC |
| | * | Commission Decision of 25 April 2007 on the withdrawal from the market of products derived from GA21xMON810 (MON-ØØØ21-9xMON-ØØ81Ø-6) maize
  (notified under document number C(2007) 1810) | 25 |
| | | 2007/309/EC |
| | * | Commission Decision of 27 April 2007 on a financial contribution from the Community towards emergency measures to combat avian influenza in Hungary in 2006
  (notified under document number C(2007) 1818) | 27 |
| | | 2007/310/EC |
| | * | Commission Decision of 27 April 2007 on a financial contribution from the Community towards emergency measures to combat avian influenza in Denmark in 2006
  (notified under document number C(2007) 1820) | 29 |

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

DECISIONS

Commission

2007/304/EC

*

Commission Decision of 25 April 2007 on the withdrawal from the market of Bt176 (SYN-EV176-9) maize and its derived products
  (notified under document number C(2007) 1804)

(notified under document number C(2007) 1804)

14

2007/305/EC

*

Commission Decision of 25 April 2007 on the withdrawal from the market of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape and its derived products
  (notified under document number C(2007) 1805)

(notified under document number C(2007) 1805)

17

2007/306/EC

*

Commission Decision of 25 April 2007 on the withdrawal from the market of Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and its derived products
  (notified under document number C(2007) 1806)

(notified under document number C(2007) 1806)

20

2007/307/EC

*

Commission Decision of 25 April 2007 on the withdrawal from the market of Topas 19/2 (ACS-BNØØ7-1) oilseed rape and its derived products
  (notified under document number C(2007) 1809)

(notified under document number C(2007) 1809)

23

2007/308/EC

*

Commission Decision of 25 April 2007 on the withdrawal from the market of products derived from GA21xMON810 (MON-ØØØ21-9xMON-ØØ81Ø-6) maize
  (notified under document number C(2007) 1810)

(notified under document number C(2007) 1810)

25

2007/309/EC

*

Commission Decision of 27 April 2007 on a financial contribution from the Community towards emergency measures to combat avian influenza in Hungary in 2006
  (notified under document number C(2007) 1818)

(notified under document number C(2007) 1818)

27

2007/310/EC

*

Commission Decision of 27 April 2007 on a financial contribution from the Community towards emergency measures to combat avian influenza in Denmark in 2006
  (notified under document number C(2007) 1820)

(notified under document number C(2007) 1820)

29

| | | Corrigenda |
| --- | --- | --- |
| | * | Corrigendum to Council Decision 2006/930/EC of 28 November 2006 concerning the conclusion of the Agreement in the form of an Exchange of Letters between the European Community and the Argentine Republic relating to the modification of concessions in the schedules of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic in the course of accession to the European Community (OJ L 355, 15.12.2006) | 31 |
| | * | Corrigendum to Council Decision 2006/963/EC of 18 December 2006 concerning the conclusion of the Agreement in the form of an Exchange of Letters between the European Community and Brazil relating to the modification of concessions in the schedules of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic in the course of accession to the European Community (OJ L 397, 30.12.2006) | 31 |

Corrigenda

*

Corrigendum to Council Decision 2006/930/EC of 28 November 2006 concerning the conclusion of the Agreement in the form of an Exchange of Letters between the European Community and the Argentine Republic relating to the modification of concessions in the schedules of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic in the course of accession to the European Community (OJ L 355, 15.12.2006)

31

*

Corrigendum to Council Decision 2006/963/EC of 18 December 2006 concerning the conclusion of the Agreement in the form of an Exchange of Letters between the European Community and Brazil relating to the modification of concessions in the schedules of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic in the course of accession to the European Community (OJ L 397, 30.12.2006)

31

| | |
| --- | --- |
| | (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

| 5.5.2007 | EN | Official Journal of the European Union | L 117/1 |
| --- | --- | --- | --- |

5.5.2007

EN

Official Journal of the European Union

L 117/1

---

COMMISSION REGULATION (EC) No 493/2007

of 4 May 2007

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 Commission Regulation (EC) No 3223/94 of 21 December 1994 on detailed rules for the application of the import arrangements for fruit and vegetables (1), and in particular Article 4(1) thereof,

Whereas:

| (1) | Regulation (EC) No 3223/94 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 the Annex thereto. |
| --- | --- |

(1)

Regulation (EC) No 3223/94 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 the Annex thereto.

| (2) | In compliance with the above criteria, the standard import values must be fixed at the levels set out in the Annex to this Regulation, |
| --- | --- |

(2)

In compliance with the above criteria, the standard import values must be fixed at the levels set out in the Annex to this Regulation,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 4 of Regulation (EC) No 3223/94 shall be fixed as indicated in the Annex hereto.

Article 2

This Regulation shall enter into force on 5 May 2007.

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

Done at Brussels, 4 May 2007.

For the Commission

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

(1)  OJ L 337, 24.12.1994, p. 66. Regulation as last amended by Regulation (EC) No 386/2005 (OJ L 62, 9.3.2005, p. 3).

1

---

ANNEX

to Commission Regulation of 4 May 2007 establishing the 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 | 37,7 |
| TN | 127,8 |
| TR | 129,0 |
| ZZ | 98,2 |
| 0707 00 05 | JO | 196,3 |
| MA | 69,3 |
| MK | 53,2 |
| TR | 102,5 |
| ZZ | 105,3 |
| 0709 90 70 | TR | 106,2 |
| ZZ | 106,2 |
| 0805 10 20 | CU | 43,2 |
| EG | 44,7 |
| IL | 69,6 |
| MA | 44,2 |
| ZZ | 50,4 |
| 0805 50 10 | AR | 52,3 |
| IL | 61,4 |
| ZZ | 56,9 |
| 0808 10 80 | AR | 81,1 |
| BR | 79,4 |
| CL | 86,9 |
| CN | 86,1 |
| NZ | 117,9 |
| US | 131,9 |
| UY | 64,7 |
| ZA | 85,7 |
| ZZ | 91,7 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

MA

37,7

TN

127,8

TR

129,0

ZZ

98,2

0707 00 05

JO

196,3

MA

69,3

MK

53,2

TR

102,5

ZZ

105,3

0709 90 70

TR

106,2

ZZ

106,2

0805 10 20

CU

43,2

EG

44,7

IL

69,6

MA

44,2

ZZ

50,4

0805 50 10

AR

52,3

IL

61,4

ZZ

56,9

0808 10 80

AR

81,1

BR

79,4

CL

86,9

CN

86,1

NZ

117,9

US

131,9

UY

64,7

ZA

85,7

ZZ

91,7

---

(1)  Country nomenclature as fixed by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ZZ’ stands for ‘of other origin’.

---

| 5.5.2007 | EN | Official Journal of the European Union | L 117/3 |
| --- | --- | --- | --- |

5.5.2007

EN

Official Journal of the European Union

L 117/3

---

COMMISSION REGULATION (EC) No 494/2007

of 4 May 2007

amending Regulation (EC) No 486/2007 fixing the import duties in the cereals sector applicable from 1 May 2007

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1784/2003 of 29 September 2003 on the common organisation of the market in cereals (1),

Having regard to Commission Regulation (EC) No 1249/96 of 28 June 1996 on rules of application (cereal sector import duties) for Council Regulation (EEC) No 1766/92 (2), and in particular Article 2(1) thereof,

Whereas:

| (1) | The import duties in the cereals sector applicable from 1 May 2007 were fixed by Commission Regulation (EC) No 486/2007 (3). |
| --- | --- |

(1)

The import duties in the cereals sector applicable from 1 May 2007 were fixed by Commission Regulation (EC) No 486/2007 (3).

| (2) | As the average of the import duties calculated differs by more than EUR 5 a tonne from that fixed, a corresponding adjustment must be made to the import duties fixed by Regulation (EC) No 486/2007. |
| --- | --- |

(2)

As the average of the import duties calculated differs by more than EUR 5 a tonne from that fixed, a corresponding adjustment must be made to the import duties fixed by Regulation (EC) No 486/2007.

| (3) | Regulation (EC) No 486/2007 should therefore be amended accordingly, |
| --- | --- |

(3)

Regulation (EC) No 486/2007 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes I and II to Regulation (EC) No 486/2007 are hereby replaced by the text in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on 5 May 2007.

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

Done at Brussels, 4 May 2007.

For the Commission

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

(1)  OJ L 270, 29.9.2003, p. 78. Regulation as amended by Commission Regulation (EC) No 1154/2005 (OJ L 187, 19.7.2005, p. 11).

1

(2)  OJ L 161, 29.6.1996, p. 125. Regulation as last amended by Regulation (EC) No 1110/2003 (OJ L 158, 27.6.2003, p. 12).

2

(3)  OJ L 114, 1.5.2007, p. 5.

3

---

ANNEX

ANNEX I

Import duties on the products referred to in Article 10(2) of Regulation (EC) No 1784/2003 applicable from 5 May 2007

| CN code | Description | Import duties (1)

  (EUR/t) |
| --- | --- | --- |
| 1001 10 00 | Durum wheat, high quality | 0,00 |
| medium quality | 0,00 |
| low quality | 0,00 |
| 1001 90 91 | Common wheat seed | 0,00 |
| ex 1001 90 99 | High quality common wheat, other than for sowing | 0,00 |
| 1002 00 00 | Rye | 0,00 |
| 1005 10 90 | Maize seed other than hybrid | 8,67 |
| 1005 90 00 | Maize, other than seed (2) | 8,67 |
| 1007 00 90 | Grain sorghum other than hybrids for sowing | 0,00 |

CN code

Description

Import duties (1)

(EUR/t)

1001 10 00

Durum wheat, high quality

0,00

medium quality

0,00

low quality

0,00

1001 90 91

Common wheat seed

0,00

ex 1001 90 99

High quality common wheat, other than for sowing

0,00

1002 00 00

Rye

0,00

1005 10 90

Maize seed other than hybrid

8,67

1005 90 00

Maize, other than seed (2)

8,67

1007 00 90

Grain sorghum other than hybrids for sowing

0,00

ANNEX II

Factors for calculating the duties laid down in Annex I

1.5.-3.5.2007

| 1. | Averages over the reference period referred to in Article 2(2) of Regulation (EC) No 1249/96:











  EUR/t |
| --- | --- |
| | Common wheat (3) | Maize | Durum wheat, high quality | Durum wheat, medium quality (4) | Durum wheat, low quality (5) | Barley |
| Exchange | Minneapolis | Chicago | — | — | — | — |
| Quotation | 156,24 | 110,83 | — | — | — | — |
| Fob price USA | — | — | 176,92 | 166,92 | 146,92 | 131,43 |
| Gulf of Mexico premium | — | 7,60 | — | — | — | — |
| Great Lakes premium | 10,98 | — | — | — | — | — |

1.

Averages over the reference period referred to in Article 2(2) of Regulation (EC) No 1249/96:

EUR/t

Common wheat (3)

Maize

Durum wheat, high quality

Durum wheat, medium quality (4)

Durum wheat, low quality (5)

Barley

Exchange

Minneapolis

Chicago

—

—

—

—

Quotation

156,24

110,83

—

—

—

—

Fob price USA

—

—

176,92

166,92

146,92

131,43

Gulf of Mexico premium

—

7,60

—

—

—

—

Great Lakes premium

10,98

—

—

—

—

—

| 2. | Averages over the reference period referred to in Article 2(2) of Regulation (EC) No 1249/96:






  Freight costs: Gulf of Mexico–Rotterdam: | 34,92 EUR/tonne |
| --- | --- | --- |
| Freight costs: Great Lakes–Rotterdam: | 34,92 EUR/tonne |

2.

Averages over the reference period referred to in Article 2(2) of Regulation (EC) No 1249/96:

Freight costs: Gulf of Mexico–Rotterdam:

34,92 EUR/tonne

Freight costs: Great Lakes–Rotterdam:

34,92 EUR/tonne

---

(1)  For goods arriving in the Community via the Atlantic Ocean or via the Suez Canal the importer may benefit, under Article 2(4) of Regulation (EC) No 1249/96, from a reduction in the duty of:

1

| — | 3 EUR/t, where the port of unloading is on the Mediterranean Sea, or |
| --- | --- |

—

3 EUR/t, where the port of unloading is on the Mediterranean Sea, or

| — | 2 EUR/t, where the port of unloading is in Denmark, Estonia, Ireland, Latvia, Lithuania, Poland, Finland, Sweden, the United Kingdom or the Atlantic coast of the Iberian peninsula. |
| --- | --- |

—

2 EUR/t, where the port of unloading is in Denmark, Estonia, Ireland, Latvia, Lithuania, Poland, Finland, Sweden, the United Kingdom or the Atlantic coast of the Iberian peninsula.

(2)  The importer may benefit from a flatrate reduction of EUR 24 per tonne where the conditions laid down in Article 2(5) of Regulation (EC) No 1249/96 are met.

2

(3)  Premium of 14 EUR/t incorporated (Article 4(3) of Regulation (EC) No 1249/96).

3

(4)  Discount of 10 EUR/t (Article 4(3) of Regulation (EC) No 1249/96).

4

(5)  Discount of 30 EUR/t (Article 4(3) of Regulation (EC) No 1249/96).

5

---

| 5.5.2007 | EN | Official Journal of the European Union | L 117/6 |
| --- | --- | --- | --- |

5.5.2007

EN

Official Journal of the European Union

L 117/6

---

COMMISSION REGULATION (EC) No 495/2007

of 4 May 2007

amending Regulation (EEC) No 3077/78 on the equivalence with Community certificates of attestations accompanying hops imported from non-member countries

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1952/2005 of 23 November 2005 concerning the common organisation of the market in hops and repealing Regulations (EEC) No 1696/71, (EEC) No 1037/72, (EEC) No 879/73 and (EEC) No 1981/82 (1), and in particular Article 17 thereof,

Whereas:

| (1) | Commission Regulation (EEC) No 3077/78 (2) lays down the list of the agencies in third countries which are authorised to issue the attestations accompanying hop products imported from those countries. Those attestations are recognised as equivalent to the certificate laid down in Article 4 of Regulation (EC) No 1952/2005. |
| --- | --- |

(1)

Commission Regulation (EEC) No 3077/78 (2) lays down the list of the agencies in third countries which are authorised to issue the attestations accompanying hop products imported from those countries. Those attestations are recognised as equivalent to the certificate laid down in Article 4 of Regulation (EC) No 1952/2005.

| (2) | Following the accession of Bulgaria and Romania to the European Union, the agencies of those new Member States should no longer appear on the list in the Annex to Regulation (EEC) No 3077/78. |
| --- | --- |

(2)

Following the accession of Bulgaria and Romania to the European Union, the agencies of those new Member States should no longer appear on the list in the Annex to Regulation (EEC) No 3077/78.

| (3) | Some of the names and addresses of the agencies listed in the Annex to Regulation (EEC) No 3077/78 have changed. |
| --- | --- |

(3)

Some of the names and addresses of the agencies listed in the Annex to Regulation (EEC) No 3077/78 have changed.

| (4) | Regulation (EEC) No 3077/78 should therefore be amended accordingly. |
| --- | --- |

(4)

Regulation (EEC) No 3077/78 should therefore be amended accordingly.

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Hops, |
| --- | --- |

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Hops,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Regulation (EEC) No 3077/78 is hereby replaced by the text in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the third 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, 4 May 2007.

For the Commission

Mariann FISCHER BOEL

Member of the Commission

---

(1)  OJ L 314, 30.11.2005, p. 1, corrected by OJ L 317, 3.12.2005, p. 29.

1

(2)  OJ L 367, 28.12.1978, p. 28. Regulation as last amended by Regulation (EC) No 81/2005 (OJ L 16, 20.1.2005, p. 52).

2

---

ANNEX

‘ANNEX

AGENCIES AUTHORISED TO ISSUE ATTESTATIONS IN RESPECT OF

Hop cones CN code: ex 1210

Hop powders CN code: ex 1210

Saps and extracts of hops CN code: 1302 13 00

| Country of origin | Agencies authorised | Address | Code | Telephone | Fax | E-mail (optional) |
| --- | --- | --- | --- | --- | --- | --- |
| Australia | Quarantine Services
  Department of Primary Industries & Water | Macquarie Wharf No 1 |
| Hunter Street, Hobart, |
| Tasmania 7000 |

Country of origin

Agencies authorised

Address

Code

Telephone

Fax

E-mail (optional)

Australia

Quarantine Services

Department of Primary Industries & Water

Macquarie Wharf No 1

Hunter Street, Hobart,

Tasmania 7000

(61-3)

6233 3352

6234 6785

Canada

Plant Protection Division, Animal and Plant Health Directorate Food Production and Inspection Branch, Agriculture and Agri-food Canada

| Floor 2, West Wing 59, |
| --- |
| Camelot Drive |
| Napean, Ontario, K1A OY9 |

Floor 2, West Wing 59,

Camelot Drive

Napean, Ontario, K1A OY9

(1-613)

952 8000

991 5612

People's Republic of China

Tianjin Airport Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China

| No 33 Youyi Road, |
| --- |
| Hexi District, |
| Tianjin 300201 |

No 33 Youyi Road,

Hexi District,

Tianjin 300201

(86-22)

281 34078

281 34078

ciqtj2002@163.com

Tianjin Economic and Technical Development Zone Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China

| No. 8, Zhaofaxincun, |
| --- |
| 2nd Avenue, TEDA, |
| Tianjin 300457 |

No. 8, Zhaofaxincun,

2nd Avenue, TEDA,

Tianjin 300457

(86-22)

662 98343

662 98245

zhujw@tjciq.gov.cn

Inner Mongolia Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China

| No 12 Erdos Street, |
| --- |
| Saihan District, Huhhot City |
| Inner Mongolia 010020 |

No 12 Erdos Street,

Saihan District, Huhhot City

Inner Mongolia 010020

(86-471)

434 1943

434 2163

zhaoxb@nmciq.gov.cn

Xinjiang Entry-Exit Inspection and Quarantine Bureau of the People's Republic of China

| No 116 North Nanhu Road, |
| --- |
| Urumqi City |
| Xinjiang 830063 |

No 116 North Nanhu Road,

Urumqi City

Xinjiang 830063

(86-991)

464 0057

464 0050

xjciq_jw@xjciq.gov.cn

New Zealand

Ministry of Agriculture and Fisheries

| PO Box 2526 |
| --- |
| Wellington |

PO Box 2526

Wellington

(64-4)

472 0367

474 424

472-9071

Gawthorn Institute

Private Bag

Nelson

(64-3)

548 2319

546 9464

Republic of Serbia

Naucni Institute za Ratarstvo/Zavod za Hmelj sirak I lekovito bilje

21470 Backi Petrovac

(38-21)

780 365

621 212

berenji@eunet.yu

South Africa

CSIR Food Science and Technology

| PO Box 395 |
| --- |
| 0001 Pretoria |

PO Box 395

0001 Pretoria

(27-12)

841 3172

841 3594

Switzerland

Labor Veritas

| Engimattstrasse 11 |
| --- |
| Postfach 353 |
| CH-8027 Zürich |

Engimattstrasse 11

Postfach 353

CH-8027 Zürich

(41-44)

283 2930

201 4249

admin@laborveritas.ch

Ukraine

Productional-Technical Centre (PTZ)

Ukrhmel

| Hlebnaja 27 |
| --- |
| 262028 Zhtiomie |

Hlebnaja 27

262028 Zhtiomie

(7-0412)

37 2111

36 7331

United States of America

Washington Department of Agriculture State Chemical and Hop Lab

| 21 N. 1st Ave. Suite 106 |
| --- |
| Yakima, WA 98902 |

21 N. 1st Ave. Suite 106

Yakima, WA 98902

(1-509)

225 7626

454 7699

Idaho Department of Agriculture

Division of Plant Industries

Hop Inspection Lab

| 2270 Old Penitentiary Road |
| --- |
| PO Box 790 |
| Boise, ID 83701 |

2270 Old Penitentiary Road

PO Box 790

Boise, ID 83701

(1-208)

332 8620

334 2283

Oregon Department of Agriculture

Commodity Inspection Division

| 635 Capital Street NE |
| --- |
| Salem, OR 97310-2532 |

635 Capital Street NE

Salem, OR 97310-2532

(1-503)

986 4620

986 4737

California Department of Food and Agriculture (CDFA-CAC)

Division of Inspection Services

Analytical Chemistry Laboratory

| 3292 Meadowview Road |
| --- |
| Sacramento, CA 95832 |

3292 Meadowview Road

Sacramento, CA 95832

(1-916)

445 0029 or 262 1434

262 1572

USDA, GIPSA, FGIS

| 1100 NW Naito Parkway |
| --- |
| Portland, OR 97209-2818 |

1100 NW Naito Parkway

Portland, OR 97209-2818

(1-503)

326 7887

326 7896

USDA, GIPSA, TSD, Tech Service Division, Technical Testing Laboratory

| 10383 Nth Ambassador Drive |
| --- |
| Kansas City, MO 64153-1394 |

10383 Nth Ambassador Drive

Kansas City, MO 64153-1394

(1-816)

891 0401

891 0478

Zimbabwe

Standards Association of Zimbabwe (SAZ)

| Northend Close, |
| --- |
| Northridge Park Borrowdale, |
| PO Box 2259 Harare |

Northend Close,

Northridge Park Borrowdale,

PO Box 2259 Harare

(263-4)

88 2017, 88 2021, 88 5511

88 2020

info@saz.org.zw

saz.org.zw’

---

| 5.5.2007 | EN | Official Journal of the European Union | L 117/9 |
| --- | --- | --- | --- |

5.5.2007

EN

Official Journal of the European Union

L 117/9

---

COMMISSION REGULATION (EC) No 496/2007

of 4 May 2007

amending Regulation (EC) No 600/2005 as regards the introduction of a maximum residue limit for the feed additive ‘Salinomax 120G’, belonging to the group of coccidiostats and other medicinal substances

(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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 13(3) thereof,

Whereas:

| (1) | The additive salinomycin sodium (Salinomax 120G) was authorised under certain conditions in accordance with Council Directive 70/524/EEC (2). Commission Regulation (EC) No 600/2005 (3) authorised that additive for 10 years for use for chickens for fattening, linking the authorisation to the person responsible for putting that additive into circulation. That additive was entered into the Community Register of Feed Additives. |
| --- | --- |

(1)

The additive salinomycin sodium (Salinomax 120G) was authorised under certain conditions in accordance with Council Directive 70/524/EEC (2). Commission Regulation (EC) No 600/2005 (3) authorised that additive for 10 years for use for chickens for fattening, linking the authorisation to the person responsible for putting that additive into circulation. That additive was entered into the Community Register of Feed Additives.

| (2) | Regulation (EC) No 1831/2003 provides for the possibility of modifying the authorisation of an additive further to a request from the holder of the authorisation and an opinion of the European Food Safety Authority (the Authority). The holder of the authorisation of the additive salinomycin sodium (Salinomax 120G) has submitted an application which proposes changing the conditions of the authorisation by introducing a maximum residue limit (MRL) as evaluated by the Authority. |
| --- | --- |

(2)

Regulation (EC) No 1831/2003 provides for the possibility of modifying the authorisation of an additive further to a request from the holder of the authorisation and an opinion of the European Food Safety Authority (the Authority). The holder of the authorisation of the additive salinomycin sodium (Salinomax 120G) has submitted an application which proposes changing the conditions of the authorisation by introducing a maximum residue limit (MRL) as evaluated by the Authority.

| (3) | In its opinion adopted on 26 January 2005 (4), the Authority proposed to establish an MRL for the active substance concerned. It may be necessary to review that MRL in the light of the results of a future evaluation of that active substance by the European Agency for the Evaluation of Medicinal Products. |
| --- | --- |

(3)

In its opinion adopted on 26 January 2005 (4), the Authority proposed to establish an MRL for the active substance concerned. It may be necessary to review that MRL in the light of the results of a future evaluation of that active substance by the European Agency for the Evaluation of Medicinal Products.

| (4) | Regulation (EC) No 600/2005 should therefore be amended accordingly. |
| --- | --- |

(4)

Regulation (EC) No 600/2005 should therefore be amended accordingly.

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(5)

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

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Regulation (EC) No 600/2005 is replaced by the text in the Annex to this Regulation.

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, 4 May 2007.

For the Commission

Markos KYPRIANOU

Member of the Commission

---

(1)  OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).

1

(2)  OJ L 270, 14.12.1970, p. 1. Directive as last amended by Commission Regulation (EC) No 1800/2004 (OJ L 317, 16.10.2004, p. 37).

2

(3)  OJ L 99, 19.4.2005, p. 5. Regulation as amended by Regulation (EC) No 2028/2006 (OJ L 414, 30.12.2006, p. 26).

3

(4)  Update of the Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on a new request from the Commission related to the safety of ‘Bio-Cox®120G’ based on Salinomycin sodium as a feed additive in accordance with Council Directive 70/524/EEC (Article 4g). Adopted on 26 January 2005, The EFSA Journal (2005) 170, p. 1-4.

4

The EFSA Journal

---

ANNEX

| Registration number of additive | Name and registration number of person responsible for putting additive into circulation | Additive
  (Trade name) | Composition, chemical formula, description | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation | Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of active substance/kg of complete feedingstuff |
| Coccidiostats and other medicinal substances |
| E 766 | Alpharma (Belgium) BVBA | Salinomycin sodium 120 g/kg (Salinomax 120G) | | Additive composition:

  Salinomycin sodium 120 g/kg
  Calcium lignosulfonate: 40 g/kg
  Calcium sulphate dihydrate to 1 000 g/kg |

Registration number of additive

Name and registration number of person responsible for putting additive into circulation

Additive

(Trade name)

Composition, chemical formula, description

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin

mg of active substance/kg of complete feedingstuff

Coccidiostats and other medicinal substances

E 766

Alpharma (Belgium) BVBA

Salinomycin sodium 120 g/kg (Salinomax 120G)

Additive composition:

Salinomycin sodium 120 g/kg

Calcium lignosulfonate: 40 g/kg

Calcium sulphate dihydrate to 1 000 g/kg

| | Active substance:

  Salinomycin sodium, C42H69O11Na,
  Sodium salt of a polyether monocarboxylic acid produced by fermentation of Streptomyces albus (ATCC 21838/US 9401-06), CAS No: 55 721-31-8
  Related impurities: | < 42 mg elaiophylin/kg salinomycin sodium. |
| --- | --- | --- |

Active substance:

Salinomycin sodium, C42H69O11Na,

Sodium salt of a polyether monocarboxylic acid produced by fermentation of Streptomyces albus (ATCC 21838/US 9401-06), CAS No: 55 721-31-8

Related impurities:

< 42 mg elaiophylin/kg salinomycin sodium.

| | < 40 g 17-epi-20 desoxysalinomycin/kg salinomycin sodium |
| --- | --- |

< 40 g 17-epi-20 desoxysalinomycin/kg salinomycin sodium

Chickens for fattening

—

50

70

Use prohibited at least one day before slaughter.

Indicate in the instructions for use:

| | ‘Dangerous for equines and turkeys’; |
| --- | --- |

‘Dangerous for equines and turkeys’;

| | ‘This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g.tiamulin) can be contraindicated’ |
| --- | --- |

‘This feedingstuff contains an ionophore: simultaneous use with certain medicinal substances (e.g.tiamulin) can be contraindicated’

22.4.2015

5 μg of Salinomycin/kg for all wet tissues

---

| 5.5.2007 | EN | Official Journal of the European Union | L 117/11 |
| --- | --- | --- | --- |

5.5.2007

EN

Official Journal of the European Union

L 117/11

---

COMMISSION REGULATION (EC) No 497/2007

of 4 May 2007

concerning the authorisation of endo-1,4-beta-xylanase EC 3.2.1.8 (Safizym X) as a feed additive

(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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

| (2) | In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the preparation set out in the Annex to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the preparation set out in the Annex to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (3) | The application concerns a new use of the preparation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma longibrachiatum (CNCM MA 6-10) (Safizym X), as a feed additive for piglets (weaned), to be classified in the additive category ‘Zootechnical additives’. |
| --- | --- |

(3)

The application concerns a new use of the preparation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma longibrachiatum (CNCM MA 6-10) (Safizym X), as a feed additive for piglets (weaned), to be classified in the additive category ‘Zootechnical additives’.

| (4) | The use of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma longibrachiatum (CNCM MA 6-10) was authorised without a time limit for chickens for fattening by Commission Regulation (EC) No 1453/2004 (2), without a time limit for turkeys for fattening by Commission Regulation (EC) No 943/2005 (3) and without a time limit for laying hens by Commission Regulation (EC) No 1810/2005 (4). |
| --- | --- |

(4)

The use of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma longibrachiatum (CNCM MA 6-10) was authorised without a time limit for chickens for fattening by Commission Regulation (EC) No 1453/2004 (2), without a time limit for turkeys for fattening by Commission Regulation (EC) No 943/2005 (3) and without a time limit for laying hens by Commission Regulation (EC) No 1810/2005 (4).

| (5) | New data were submitted in support of an application for authorisation for piglets (weaned). The European Food Safety Authority (the Authority) concluded in its opinion of 17 October 2006 that the preparation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma longibrachiatum (CNCM MA 6-10) (Safizym X) does not have an adverse effect on animal health, human health or the environment (5). It further concluded that that preparation does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. According to that opinion, the use of that preparation does not have an adverse effect on these additional animal categories. The Authority does not consider that there is a need for specific requirements of post market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(5)

New data were submitted in support of an application for authorisation for piglets (weaned). The European Food Safety Authority (the Authority) concluded in its opinion of 17 October 2006 that the preparation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma longibrachiatum (CNCM MA 6-10) (Safizym X) does not have an adverse effect on animal health, human health or the environment (5). It further concluded that that preparation does not present any other risk which would, in accordance with Article 5(2) of Regulation (EC) No 1831/2003, exclude authorisation. According to that opinion, the use of that preparation does not have an adverse effect on these additional animal categories. The Authority does not consider that there is a need for specific requirements of post market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Community Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (6) | The assessment of that preparation shows that the conditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation. |
| --- | --- |

(6)

The assessment of that preparation shows that the conditions for authorisation, provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised, as specified in the Annex to this Regulation.

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

(7)

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

HAS ADOPTED THIS REGULATION:

Article 1

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.

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, 4 May 2007.

For the Commission

Markos KYPRIANOU

Member of the Commission

---

(1)  OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commission Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).

1

(2)  OJ L 269, 17.8.2004, p. 3.

2

(3)  OJ L 159, 22.6.2005, p. 6.

3

(4)  OJ L 291, 5.11.2005, p. 5. Regulation as amended by Regulation (EC) No 184/2007 (OJ L 63, 1.3.2007, p. 1).

4

(5)  Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the enzyme preparation Safizym X (endo-1,4-beta-xylanase) as feed additive for piglets in accordance with Regulation (EC) No 1831/2003. Adopted on 17 October 2006, The EFSA Journal (2006) 405, 1-10.

5

The EFSA Journal

---

ANNEX

| Identification number of the additive | Name of the holder of authorisation | Additive
  (Trade name) | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Unit of activity/kg of complete feedingstuff with a moisture content of 12 % |
| Category of zootechnical additives. Functional group: digestibility enhancers |
| 4a1613 | Société Industrielle Lesaffre | Endo-1,4-beta-xylanase
  EC 3.2.1.8
  (Safizym X) | | Additive composition:

  Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (CNCM MA 6-10W) having a minimum activity of: | Powder form: 70 000 IFP (1)/g |

Identification number of the additive

Name of the holder of authorisation

Additive

(Trade name)

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Unit of activity/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers

4a1613

Société Industrielle Lesaffre

Endo-1,4-beta-xylanase

EC 3.2.1.8

(Safizym X)

Additive composition:

Preparation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (CNCM MA 6-10W) having a minimum activity of:

Powder form: 70 000 IFP (1)/g

| | Liquid form: 7 000 IFP/ml |
| --- | --- |

Liquid form: 7 000 IFP/ml

| | Characterisation of the active substance:

  endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (CNCM MA 6-10W) |
| --- | --- |

Characterisation of the active substance:

endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum (CNCM MA 6-10W)

| | Analytical method
   (2)

  Reducing sugar assay for endo-1,4-beta-xylanase by colorimetric reaction of dinitrosalicylic acid reagent on reducing sugar yield. |
| --- | --- |

Analytical method
   (2)

Reducing sugar assay for endo-1,4-beta-xylanase by colorimetric reaction of dinitrosalicylic acid reagent on reducing sugar yield.

Piglets (weaned)

—

840 IFP

| 1. | In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting. |
| --- | --- |

1.

In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

| 2. | Recommended dose per kilogram of complete feedingstuff: 1 680 IFP. |
| --- | --- |

2.

Recommended dose per kilogram of complete feedingstuff: 1 680 IFP.

| 3. | For piglets (weaned) up to 35 kg of body weight. |
| --- | --- |

3.

For piglets (weaned) up to 35 kg of body weight.

| 4. | For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 20 % wheat. |
| --- | --- |

4.

For use in compound feed rich in non-starch polysaccharides (mainly arabinoxylans), e.g. containing more than 20 % wheat.

25.5.2017

---

(1)  1 IFP is the amount of enzyme which liberates 1 micromole of reducing sugars (xylose equivalents) from oat xylan per minute at pH 4,8 and 50 °C.

(2)  Details of the analytical methods are available at the following address of the Community Reference Laboratory: www.irmm.jrc.be/html/crlfaa/

---

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

DECISIONS

Commission

| 5.5.2007 | EN | Official Journal of the European Union | L 117/14 |
| --- | --- | --- | --- |

5.5.2007

EN

Official Journal of the European Union

L 117/14

---

COMMISSION DECISION

of 25 April 2007

on the withdrawal from the market of Bt176 (SYN-EV176-9) maize and its derived products

(notified under document number C(2007) 1804)

(Only the English text is authentic)

(2007/304/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 the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Article 8(6) and 20(6) thereof,

Whereas:

| (1) | Bt176 (SYN-EV176-9) maize has been granted consent pursuant to Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (2) by Commission Decision 97/98/EC of 23 January 1997 concerning the placing on the market of genetically modified maize (Zea mays L.) with the combined modification for insecticidal properties conferred by the Bt-endotoxin gene and increased tolerance to the herbicide glufosinate ammonium, on application of Council Directive 90/220/EEC (3). Directive 90/220/EEC has been recast and repealed by Directive 2001/18/EC. |
| --- | --- |

(1)

Bt176 (SYN-EV176-9) maize has been granted consent pursuant to Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (2) by Commission Decision 97/98/EC of 23 January 1997 concerning the placing on the market of genetically modified maize (Zea mays L.) with the combined modification for insecticidal properties conferred by the Bt-endotoxin gene and increased tolerance to the herbicide glufosinate ammonium, on application of Council Directive 90/220/EEC (3). Directive 90/220/EEC has been recast and repealed by Directive 2001/18/EC.

| (2) | The consent was based on the respective opinions of the Scientific Committee for Animal Nutrition established by Commission Decision 76/791/EEC (4), of the Scientific Committee for Food established by Commission Decision 95/273/EC (5) and of the Scientific Committee for Pesticides established by Commission Decision 78/436/EEC (6). |
| --- | --- |

(2)

The consent was based on the respective opinions of the Scientific Committee for Animal Nutrition established by Commission Decision 76/791/EEC (4), of the Scientific Committee for Food established by Commission Decision 95/273/EC (5) and of the Scientific Committee for Pesticides established by Commission Decision 78/436/EEC (6).

| (3) | SYN-EV176-9 maize and its derived products have subsequently been notified by Syngenta Crop Protection AG (hereafter ‘the notifier’) as existing products under Article 8(1) and Article 20(1) of Regulation (EC) No 1829/2003 (hereafter ‘the Regulation’) and entered in the Community Register of genetically modified food and feed. The scope of the notification covered food consisting of and/or containing or produced from SYN-EV176-9 maize, food additives produced from SYN-EV176-9 maize, feed consisting of and/or containing SYN-EV176-9 maize, feed materials produced from SYN-EV176-9 maize and feed additives produced from SYN-EV176-9 maize. |
| --- | --- |

(3)

SYN-EV176-9 maize and its derived products have subsequently been notified by Syngenta Crop Protection AG (hereafter ‘the notifier’) as existing products under Article 8(1) and Article 20(1) of Regulation (EC) No 1829/2003 (hereafter ‘the Regulation’) and entered in the Community Register of genetically modified food and feed. The scope of the notification covered food consisting of and/or containing or produced from SYN-EV176-9 maize, food additives produced from SYN-EV176-9 maize, feed consisting of and/or containing SYN-EV176-9 maize, feed materials produced from SYN-EV176-9 maize and feed additives produced from SYN-EV176-9 maize.

| (4) | The notifier of SYN-EV176-9 maize, in a letter to the Commission dated 19 September 2005, indicated that it has stopped selling seeds of SYN-EV176-9 maize in the Community after the 2005 planting season. |
| --- | --- |

(4)

The notifier of SYN-EV176-9 maize, in a letter to the Commission dated 19 September 2005, indicated that it has stopped selling seeds of SYN-EV176-9 maize in the Community after the 2005 planting season.

| (5) | The notifier has further indicated to the Commission that it has no intention to submit an application for renewal of the authorisation of SYN-EV176-9 maize under the Regulation in accordance with Article 8(4), Article 11, Article 20(4) and Article 23 respectively. Therefore neither the cultivation nor the placing on the market of SYN-EV176-9 maize and its derived products will be authorised in the Community after 18 April 2007. |
| --- | --- |

(5)

The notifier has further indicated to the Commission that it has no intention to submit an application for renewal of the authorisation of SYN-EV176-9 maize under the Regulation in accordance with Article 8(4), Article 11, Article 20(4) and Article 23 respectively. Therefore neither the cultivation nor the placing on the market of SYN-EV176-9 maize and its derived products will be authorised in the Community after 18 April 2007.

| (6) | Measures should therefore be adopted in order to ensure effective withdrawal from the market of seeds from inbred lines and hybrids derived from SYN-EV176-9 maize. As a consequence of the non-availability of seeds, any products derived from SYN-ENV176-9 maize can be expected to disappear from the food and feed chain in a reasonable period of time. |
| --- | --- |

(6)

Measures should therefore be adopted in order to ensure effective withdrawal from the market of seeds from inbred lines and hybrids derived from SYN-EV176-9 maize. As a consequence of the non-availability of seeds, any products derived from SYN-ENV176-9 maize can be expected to disappear from the food and feed chain in a reasonable period of time.

| (7) | Since the notifier has stopped selling seeds of SYN-EV176-9 maize in the Community after the 2005 planting season, stocks of products derived from SYN-EV176-9 maize have been used up and are not expected to be present on the market after 18 April 2007. However, minute traces of genetically modified material from SYN-EV176-9 maize might remain present in food or feed products for a certain period of time. |
| --- | --- |

(7)

Since the notifier has stopped selling seeds of SYN-EV176-9 maize in the Community after the 2005 planting season, stocks of products derived from SYN-EV176-9 maize have been used up and are not expected to be present on the market after 18 April 2007. However, minute traces of genetically modified material from SYN-EV176-9 maize might remain present in food or feed products for a certain period of time.

| (8) | For reasons of legal certainty, it is therefore necessary to provide for a transitional period of time within which food and feed products may contain such material without being considered to be in breach of Article 4(2) or Article 16(2) of the Regulation where this presence is adventitious or technically unavoidable. |
| --- | --- |

(8)

For reasons of legal certainty, it is therefore necessary to provide for a transitional period of time within which food and feed products may contain such material without being considered to be in breach of Article 4(2) or Article 16(2) of the Regulation where this presence is adventitious or technically unavoidable.

| (9) | The tolerated level and the period of time should be set taking into account the time needed until the effective withdrawal from the market of the seeds produces its effects throughout the food and feed chain. In all cases, the tolerated level shall remain below the labelling and traceability threshold of no higher than 0,9 % provided for by the Regulation for the adventitious or technically unavoidable presence of GM material in food and feed. |
| --- | --- |

(9)

The tolerated level and the period of time should be set taking into account the time needed until the effective withdrawal from the market of the seeds produces its effects throughout the food and feed chain. In all cases, the tolerated level shall remain below the labelling and traceability threshold of no higher than 0,9 % provided for by the Regulation for the adventitious or technically unavoidable presence of GM material in food and feed.

| (10) | The entries in the Community Register of genetically modified food and feed, as provided for in Article 28 of the Regulation, regarding SYN-EV176-9 maize should be modified in order to take account of this Decision. |
| --- | --- |

(10)

The entries in the Community Register of genetically modified food and feed, as provided for in Article 28 of the Regulation, regarding SYN-EV176-9 maize should be modified in order to take account of this Decision.

| (11) | The notifier has been consulted on the measures provided for in this Decision. |
| --- | --- |

(11)

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

| (12) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(12)

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

In order to ensure effective withdrawal from the market of seeds from inbred lines and hybrids derived from SYN-EV176-9 maize for the purpose of cultivation the notifier shall comply with the measures set out in the Annex.

Within 6 months from the date of notification of this Decision, the notifier shall submit to the Commission a report on the implementation of the measures set out in the Annex.

Article 2

The presence of material which contains, consists of or is produced from SYN-EV176-9 maize in food or feed products notified under Article 8(1) and Article 20(1) of the Regulation shall be tolerated until 5 years after the date of notification of this Decision:

| (a) | provided that this presence is adventitious or technically unavoidable; and |
| --- | --- |

(a)

provided that this presence is adventitious or technically unavoidable; and

| (b) | in a proportion no higher than 0,9 %. |
| --- | --- |

(b)

in a proportion no higher than 0,9 %.

Article 3

The entries in the Community Register of genetically modified food and feed, as provided for in Article 28 of the Regulation, regarding SYN-EV176-9 maize shall be modified in order to take account of this Decision.

Article 4

This Decision is addressed to Syngenta Crop Protection AG, P.O. Box, CH-4002 Basel, Switzerland.

Done at Brussels, 25 April 2007.

For the Commission

Markos KYPRIANOU

Member of the Commission

---

(1)  OJ L 268, 18.10.2003, p. 1. Regulation as amended by Commission Regulation (EC) No 1981/2006 (OJ L 368, 23.12.2006, p. 99).

1

(2)  OJ L 117, 8.5.1990, p. 15. Directive as repealed by Directive 2001/18/EC of the European Parliament and of the Council (OJ L 106, 17.4.2001, p. 1).

2

(3)  OJ L 31, 1.2.1997, p. 69.

3

(4)  OJ L 279, 9.10.1976, p. 35.

4

(5)  OJ L 167, 18.7.1995, p. 22.

5

(6)  OJ L 124, 12.5.1978, p. 16.

6

---

ANNEX

Measures to be complied with by the notifier in order to ensure effective withdrawal from the market of seeds from inbred lines and hybrids derived from SYN-EV176-9 maize for the purpose of cultivation

| (a) | Inform commercial operators in the Community of the commercial and legal status of the seed. |
| --- | --- |

(a)

Inform commercial operators in the Community of the commercial and legal status of the seed.

| (b) | Recall remaining commercial seed stock held by operators. |
| --- | --- |

(b)

Recall remaining commercial seed stock held by operators.

| (c) | Destroy remaining commercial seed stock. |
| --- | --- |

(c)

Destroy remaining commercial seed stock.

| (d) | Conclude product discontinuation agreements with third parties instructing them to either send back seed or to verify and attest that the seed has been destroyed. |
| --- | --- |

(d)

Conclude product discontinuation agreements with third parties instructing them to either send back seed or to verify and attest that the seed has been destroyed.

| (e) | Undertake all necessary steps for the deregistration of registered varieties of the seed from the national seed catalogues. |
| --- | --- |

(e)

Undertake all necessary steps for the deregistration of registered varieties of the seed from the national seed catalogues.

| (f) | Implement an in-house program to avoid presence of the event in breeding and seed production. |
| --- | --- |

(f)

Implement an in-house program to avoid presence of the event in breeding and seed production.

---

| 5.5.2007 | EN | Official Journal of the European Union | L 117/17 |
| --- | --- | --- | --- |

5.5.2007

EN

Official Journal of the European Union

L 117/17

---

COMMISSION DECISION

of 25 April 2007

on the withdrawal from the market of Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) hybrid oilseed rape and its derived products

(notified under document number C(2007) 1805)

(Only the German text is authentic)

(2007/305/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 the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Article 8(6) and 20(6) thereof,

Whereas:

| (1) | Seeds of hybrid oilseed rape Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) have been granted consent pursuant to Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (2) by Commission Decision 96/158/EC of 6 February 1996 concerning the placing on the market of a product consisting of a genetically modified organism, hybrid herbicide-tolerant swede-rape seeds (Brassica napus L. oleifera Metzq. MS1Bn x RF1Bn) (3) for the use of growing for obtaining seed but not for the use for human food or animal feed. Directive 90/220/EEC has been recast and repealed by Directive 2001/18/EC. |
| --- | --- |

(1)

Seeds of hybrid oilseed rape Ms1xRf1 (ACS-BNØØ4-7xACS-BNØØ1-4) have been granted consent pursuant to Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (2) by Commission Decision 96/158/EC of 6 February 1996 concerning the placing on the market of a product consisting of a genetically modified organism, hybrid herbicide-tolerant swede-rape seeds (Brassica napus L. oleifera Metzq. MS1Bn x RF1Bn) (3) for the use of growing for obtaining seed but not for the use for human food or animal feed. Directive 90/220/EEC has been recast and repealed by Directive 2001/18/EC.

| (2) | Seeds of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ1-4 have been granted consent pursuant to Council Directive 90/220/EEC by Commission Decision 97/392/EC of 6 June 1997 concerning the placing on the market of genetically modified swede-rape (Brassica napus L. oleifera Metzg. MS1, RF1) pursuant to Council Directive 90/220/EEC (4) for the intended use of growing and handling in the environment before and during processing to non-viable fractions. |
| --- | --- |

(2)

Seeds of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ1-4 have been granted consent pursuant to Council Directive 90/220/EEC by Commission Decision 97/392/EC of 6 June 1997 concerning the placing on the market of genetically modified swede-rape (Brassica napus L. oleifera Metzg. MS1, RF1) pursuant to Council Directive 90/220/EEC (4) for the intended use of growing and handling in the environment before and during processing to non-viable fractions.

| (3) | The consents were based on the information contained in the dossiers submitted under Directive 90/220/EEC and all the information submitted by the Member States. |
| --- | --- |

(3)

The consents were based on the information contained in the dossiers submitted under Directive 90/220/EEC and all the information submitted by the Member States.

| (4) | Processed oil from ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape was placed on the market in accordance with Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (5). |
| --- | --- |

(4)

Processed oil from ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape was placed on the market in accordance with Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (5).

| (5) | ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape and their derived products have subsequently been notified by Bayer CropScience AG (hereafter the notifier) as existing products under Article 8(1)(a) and Article 20(1) of Regulation (EC) No 1829/2003 (hereafter the Regulation) and entered in the Community Register of genetically modified food and feed. The scope of the notification covered food (processed oil) produced from the male sterile MS1Bn (B91-4) oilseed rape line and all conventional crosses, the fertility restorer RF1Bn (B93-101) oilseed rape line and all conventional crosses and the hybrid combination MS1xRF1 (ACS-BNØØ4-7xACS-BNØØ1-4) as well as feed containing or consisting of oilseed swede-rape derived from the male sterile MS1 (B91-4), cultivar Drakkar, oilseed rape line (Brassica napus L. oleifera Metzg.), the fertility restorer RF1 (B93-101), cultivar Drakkar, oilseed rape line (Brassica napus L. oleifera Metzg.) and the hybrid combination MS1xRF1 (ACS-BNØØ4-7xACS-BNØØ1-4) (Brassica napus L. oleifera Metzg. MS1Bn x RF1Bn) for the intended uses of growing and handling in the environment before and during processing to non-viable fractions. |
| --- | --- |

(5)

ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape and their derived products have subsequently been notified by Bayer CropScience AG (hereafter the notifier) as existing products under Article 8(1)(a) and Article 20(1) of Regulation (EC) No 1829/2003 (hereafter the Regulation) and entered in the Community Register of genetically modified food and feed. The scope of the notification covered food (processed oil) produced from the male sterile MS1Bn (B91-4) oilseed rape line and all conventional crosses, the fertility restorer RF1Bn (B93-101) oilseed rape line and all conventional crosses and the hybrid combination MS1xRF1 (ACS-BNØØ4-7xACS-BNØØ1-4) as well as feed containing or consisting of oilseed swede-rape derived from the male sterile MS1 (B91-4), cultivar Drakkar, oilseed rape line (Brassica napus L. oleifera Metzg.), the fertility restorer RF1 (B93-101), cultivar Drakkar, oilseed rape line (Brassica napus L. oleifera Metzg.) and the hybrid combination MS1xRF1 (ACS-BNØØ4-7xACS-BNØØ1-4) (Brassica napus L. oleifera Metzg. MS1Bn x RF1Bn) for the intended uses of growing and handling in the environment before and during processing to non-viable fractions.

| (6) | The notifier of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ1-4, in a letter to the Commission dated 15 November 2005, indicated that varieties containing this event were no longer offered for sale on a global basis and that all inventory seed were recalled and destroyed after the 2003 sales season. |
| --- | --- |

(6)

The notifier of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ1-4, in a letter to the Commission dated 15 November 2005, indicated that varieties containing this event were no longer offered for sale on a global basis and that all inventory seed were recalled and destroyed after the 2003 sales season.

| (7) | The notifier has further indicated to the Commission that it has no intention to submit an application for renewal of the authorisation of ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape under the Regulation in accordance with the first sub-paragraph of Article 8(4), Article 11, Article 20(4) and Article 23 respectively. Therefore neither the cultivation nor the placing on the market of ACS-BNØØ4-7xACS-BNØØ1-4 hybrid oilseed rape and its derived products will be authorised in the Community after 18 April 2007. |
| --- | --- |

(7)

The notifier has further indicated to the Commission that it has no intention to submit an application for renewal of the authorisation of ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape under the Regulation in accordance with the first sub-paragraph of Article 8(4), Article 11, Article 20(4) and Article 23 respectively. Therefore neither the cultivation nor the placing on the market of ACS-BNØØ4-7xACS-BNØØ1-4 hybrid oilseed rape and its derived products will be authorised in the Community after 18 April 2007.

| (8) | Measures should therefore be adopted in order to ensure effective withdrawal from the market of seeds of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ1-4. As a consequence of the non-availability of seeds, any products derived from ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape can be expected to disappear from the food and feed chain in a reasonable period of time. |
| --- | --- |

(8)

Measures should therefore be adopted in order to ensure effective withdrawal from the market of seeds of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ1-4. As a consequence of the non-availability of seeds, any products derived from ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape can be expected to disappear from the food and feed chain in a reasonable period of time.

| (9) | Since the notifier has stopped selling seeds of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ1-4 after the 2003 planting season, stocks of products derived from ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape have been used up and are not expected to be present on the market after 18 April 2007. However, minute traces of genetically modified material from ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape might remain present in food or feed products for a certain period of time. |
| --- | --- |

(9)

Since the notifier has stopped selling seeds of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ1-4 after the 2003 planting season, stocks of products derived from ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape have been used up and are not expected to be present on the market after 18 April 2007. However, minute traces of genetically modified material from ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape might remain present in food or feed products for a certain period of time.

| (10) | For reasons of legal certainty, it is therefore necessary to provide for a transitional period of time within which food and feed products may contain such material without being considered to be in breach of Article 4(2) or Article 16(2) of the Regulation where this presence is adventitious or technically unavoidable. |
| --- | --- |

(10)

For reasons of legal certainty, it is therefore necessary to provide for a transitional period of time within which food and feed products may contain such material without being considered to be in breach of Article 4(2) or Article 16(2) of the Regulation where this presence is adventitious or technically unavoidable.

| (11) | The tolerated level and the period of time should be set taking into account the time needed until the effective withdrawal from the market of the seeds produces its effects throughout the food and feed chain. In all cases, the tolerated level shall remain below the labelling and traceability threshold of no higher than 0,9 % provided for by the Regulation for the adventitious or technically unavoidable presence of GM material in food and feed. |
| --- | --- |

(11)

The tolerated level and the period of time should be set taking into account the time needed until the effective withdrawal from the market of the seeds produces its effects throughout the food and feed chain. In all cases, the tolerated level shall remain below the labelling and traceability threshold of no higher than 0,9 % provided for by the Regulation for the adventitious or technically unavoidable presence of GM material in food and feed.

| (12) | The entries in the Community Register of genetically modified food and feed, as provided for in Article 28 of the Regulation, regarding ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape should be modified in order to take account of this Decision. |
| --- | --- |

(12)

The entries in the Community Register of genetically modified food and feed, as provided for in Article 28 of the Regulation, regarding ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape should be modified in order to take account of this Decision.

| (13) | The notifier has been consulted on the measures provided for in this Decision. |
| --- | --- |

(13)

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

| (14) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(14)

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

In order to ensure effective withdrawal from the market of seeds of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ1-4 for the purpose of cultivation the notifier shall comply with the measures set out in the Annex.

Within six months from the date of notification of this Decision, the notifier shall submit to the Commission a report on the implementation of the measures set out in the Annex.

Article 2

The presence of material which contains, consists of or is produced from ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape in food or feed products notified under Article 8(1)(a) and Article 20(1) of the Regulation shall be tolerated until five years after the date of notification of this Decision:

| (a) | provided that this presence is adventitious or technically unavoidable; and |
| --- | --- |

(a)

provided that this presence is adventitious or technically unavoidable; and

| (b) | in a proportion no higher than 0,9 %. |
| --- | --- |

(b)

in a proportion no higher than 0,9 %.

Article 3

The entries in the Community Register of genetically modified food and feed, as provided for in Article 28 of the Regulation, regarding ACS-BNØØ4-7, ACS-BNØØ1-4 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ1-4 oilseed rape shall be modified in order to take account of this Decision.

Article 4

This Decision is addressed to Bayer CropScience AG, Alfred-Nobel-Str. 50, D-40789 Monheim am Rhein, Germany.

Done at Brussels, 25 April 2007.

For the Commission

Markos KYPRIANOU

Member of the Commission

---

(1)  OJ L 268, 18.10.2003, p. 1. Regulation as amended by Commission Regulation (EC) No 1981/2006 (OJ L 368, 23.12.2006, p. 99).

1

(2)  OJ L 117, 8.5.1990, p. 15. Directive as repealed by Directive 2001/18/EC of the European Parliament and the Council (OJ L 106, 17.4.2001, p. 1).

2

(3)  OJ L 37, 15.2.1996, p. 30.

3

(4)  OJ L 164, 21.6.1997, p. 38.

4

(5)  OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

5

---

ANNEX

Measures to be complied with by the notifier in order to ensure effective withdrawal from the market of seeds of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ1-4 for the purpose of cultivation

| (a) | Inform commercial operators in the Community of the commercial and legal status of the seed. |
| --- | --- |

(a)

Inform commercial operators in the Community of the commercial and legal status of the seed.

| (b) | Recall remaining commercial seed stock held by operators. |
| --- | --- |

(b)

Recall remaining commercial seed stock held by operators.

| (c) | Destroy remaining commercial seed stock. |
| --- | --- |

(c)

Destroy remaining commercial seed stock.

| (d) | Conclude product discontinuation agreements with third parties instructing them to either send back seed or to verify and attest that the seed has been destroyed. |
| --- | --- |

(d)

Conclude product discontinuation agreements with third parties instructing them to either send back seed or to verify and attest that the seed has been destroyed.

| (e) | Undertake all necessary steps for the deregistration of registered varieties of the seed from the national seed catalogues. |
| --- | --- |

(e)

Undertake all necessary steps for the deregistration of registered varieties of the seed from the national seed catalogues.

| (f) | Implement an in-house program to avoid presence of the event in breeding and seed production. |
| --- | --- |

(f)

Implement an in-house program to avoid presence of the event in breeding and seed production.

---

| 5.5.2007 | EN | Official Journal of the European Union | L 117/20 |
| --- | --- | --- | --- |

5.5.2007

EN

Official Journal of the European Union

L 117/20

---

COMMISSION DECISION

of 25 April 2007

on the withdrawal from the market of Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) hybrid oilseed rape and its derived products

(notified under document number C(2007) 1806)

(Only the German text is authentic)

(2007/306/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 the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Article 8(6) and 20(6) thereof,

Whereas:

| (1) | Seeds of hybrid oilseed rape Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) have been granted consent pursuant to Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (2) by Commission Decision 97/393/EC of 6 June 1997 concerning the placing on the market of genetically modified swede-rape (Brassica napus L. oleifera Metzg. MS1, RF2), in accordance with Council Directive 90/220/EEC (3), for the intended use of growing and handling in the environment before and during processing to non-viable fractions. Directive 90/220/EEC has been recast and repealed by Directive 2001/18/EC. |
| --- | --- |

(1)

Seeds of hybrid oilseed rape Ms1xRf2 (ACS-BNØØ4-7xACS-BNØØ2-5) have been granted consent pursuant to Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (2) by Commission Decision 97/393/EC of 6 June 1997 concerning the placing on the market of genetically modified swede-rape (Brassica napus L. oleifera Metzg. MS1, RF2), in accordance with Council Directive 90/220/EEC (3), for the intended use of growing and handling in the environment before and during processing to non-viable fractions. Directive 90/220/EEC has been recast and repealed by Directive 2001/18/EC.

| (2) | The consent was based on the information contained in the dossier submitted under Directive 90/220/EEC and all the information submitted by the Member States. |
| --- | --- |

(2)

The consent was based on the information contained in the dossier submitted under Directive 90/220/EEC and all the information submitted by the Member States.

| (3) | Processed oil from ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape was placed on the market in accordance with Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (4). |
| --- | --- |

(3)

Processed oil from ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape was placed on the market in accordance with Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (4).

| (4) | ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape and their derived products have subsequently been notified as existing products by Bayer CropScience AG (hereafter ‘the notifier’) under Article 8(1)(a) and Article 20(1) of Regulation (EC) No 1829/2003 (hereafter ‘the Regulation’) and entered in the Community Register of genetically modified food and feed. The scope of the notification covered food (processed oil) produced from the male sterile MS1Bn (B91-4) oilseed rape line and all conventional crosses, the fertility restorer RF2Bn (B94-2) oilseed rape line and all conventional crosses and the hybrid combination MS1xRF2 (ACS-BNØØ4-7xACS-BNØØ2-5)) as well as feed containing or consisting of oilseed swede-rape derived from the male sterile MS1 (B91-4), cultivar Drakkar, oilseed rape line (Brassica napus L. oleifera Metzg.), the fertility restorer RF2 (B94-2), cultivar Drakkar, oilseed rape line (Brassica napus L. oleifera Metzg.) and the hybrid combination MS1xRF2 (ACS-BNØØ4-7xACS-BNØØ2-5) (Brassica napus L. oleifera Metzg. MS1Bn x RF2Bn) for the intended uses of growing and handling in the environment before and during processing to non-viable fractions. |
| --- | --- |

(4)

ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape and their derived products have subsequently been notified as existing products by Bayer CropScience AG (hereafter ‘the notifier’) under Article 8(1)(a) and Article 20(1) of Regulation (EC) No 1829/2003 (hereafter ‘the Regulation’) and entered in the Community Register of genetically modified food and feed. The scope of the notification covered food (processed oil) produced from the male sterile MS1Bn (B91-4) oilseed rape line and all conventional crosses, the fertility restorer RF2Bn (B94-2) oilseed rape line and all conventional crosses and the hybrid combination MS1xRF2 (ACS-BNØØ4-7xACS-BNØØ2-5)) as well as feed containing or consisting of oilseed swede-rape derived from the male sterile MS1 (B91-4), cultivar Drakkar, oilseed rape line (Brassica napus L. oleifera Metzg.), the fertility restorer RF2 (B94-2), cultivar Drakkar, oilseed rape line (Brassica napus L. oleifera Metzg.) and the hybrid combination MS1xRF2 (ACS-BNØØ4-7xACS-BNØØ2-5) (Brassica napus L. oleifera Metzg. MS1Bn x RF2Bn) for the intended uses of growing and handling in the environment before and during processing to non-viable fractions.

| (5) | The notifier of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ2-5, in a letter to the Commission dated 15 November 2005, indicated that varieties containing this event were no longer offered for sale on a global basis and that all inventory seed were recalled and destroyed after the 2003 sales season. |
| --- | --- |

(5)

The notifier of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ2-5, in a letter to the Commission dated 15 November 2005, indicated that varieties containing this event were no longer offered for sale on a global basis and that all inventory seed were recalled and destroyed after the 2003 sales season.

| (6) | The notifier has further indicated to the Commission that it has no intention to submit an application for renewal of the authorisation of ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape under the Regulation in accordance with the first sub-paragraph of Article 8(4), Article 11, Article 20(4) and Article 23 respectively. Therefore neither the cultivation nor the placing on the market of ACS-BNØØ4-7xACS-BNØØ2-5 hybrid oilseed rape and its derived products will be authorised in the Community after 18 April 2007. |
| --- | --- |

(6)

The notifier has further indicated to the Commission that it has no intention to submit an application for renewal of the authorisation of ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape under the Regulation in accordance with the first sub-paragraph of Article 8(4), Article 11, Article 20(4) and Article 23 respectively. Therefore neither the cultivation nor the placing on the market of ACS-BNØØ4-7xACS-BNØØ2-5 hybrid oilseed rape and its derived products will be authorised in the Community after 18 April 2007.

| (7) | Measures should therefore be adopted in order to ensure effective withdrawal from the market of seeds of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ2-5. As a consequence of the non-availability of seeds, any products derived from ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape can be expected to disappear from the food and feed chain in a reasonable period of time. |
| --- | --- |

(7)

Measures should therefore be adopted in order to ensure effective withdrawal from the market of seeds of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ2-5. As a consequence of the non-availability of seeds, any products derived from ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape can be expected to disappear from the food and feed chain in a reasonable period of time.

| (8) | Since the notifier has stopped selling seeds of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ2-5 after the 2003 planting season, stocks of products derived from ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape have been used up and are not expected to be present on the market after 18 April 2007. However, minute traces of genetically modified material from ACS-BNØØ4-7, ACS-BNØØ2-5 and ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape might remain present in food or feed products for a certain period of time. |
| --- | --- |

(8)

Since the notifier has stopped selling seeds of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ2-5 after the 2003 planting season, stocks of products derived from ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape have been used up and are not expected to be present on the market after 18 April 2007. However, minute traces of genetically modified material from ACS-BNØØ4-7, ACS-BNØØ2-5 and ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape might remain present in food or feed products for a certain period of time.

| (9) | For reasons of legal certainty, it is therefore necessary to provide for a transitional period of time within which food and feed products may contain such material without being considered to be in breach of Article 4(2) or Article 16(2) of the Regulation where this presence is adventitious or technically unavoidable. |
| --- | --- |

(9)

For reasons of legal certainty, it is therefore necessary to provide for a transitional period of time within which food and feed products may contain such material without being considered to be in breach of Article 4(2) or Article 16(2) of the Regulation where this presence is adventitious or technically unavoidable.

| (10) | The tolerated level and the period of time should be set taking into account the time needed until the effective withdrawal from the market of the seeds produces its effects throughout the food and feed chain. In all cases, the tolerated level shall remain below the labelling and traceability threshold of no higher than 0,9 % provided for by the Regulation for the adventitious or technically unavoidable presence of GM material in food and feed. |
| --- | --- |

(10)

The tolerated level and the period of time should be set taking into account the time needed until the effective withdrawal from the market of the seeds produces its effects throughout the food and feed chain. In all cases, the tolerated level shall remain below the labelling and traceability threshold of no higher than 0,9 % provided for by the Regulation for the adventitious or technically unavoidable presence of GM material in food and feed.

| (11) | The entries in the Community Register of genetically modified food and feed, as provided for in Article 28 of the Regulation, regarding ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape should be modified in order to take account of this Decision. |
| --- | --- |

(11)

The entries in the Community Register of genetically modified food and feed, as provided for in Article 28 of the Regulation, regarding ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape should be modified in order to take account of this Decision.

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

(12)

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

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

(13)

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

HAS ADOPTED THIS DECISION:

Article 1

In order to ensure effective withdrawal from the market of seeds of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ2-5 for the purpose of cultivation the notifier shall comply with the measures set out in the Annex.

Within six months from the date of notification of this Decision, the notifier shall submit to the Commission a report on the implementation of the measures set out in the Annex.

Article 2

The presence of material which contains, consists of or is produced from ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape in food or feed products notified under Article 8(1)(a) and Article 20(1) of the Regulation shall be tolerated until five years after the date of notification of this Decision:

| (a) | provided that this presence is adventitious or technically unavoidable; and |
| --- | --- |

(a)

provided that this presence is adventitious or technically unavoidable; and

| (b) | in a proportion no higher than 0,9 %. |
| --- | --- |

(b)

in a proportion no higher than 0,9 %.

Article 3

The entries in the Community Register of genetically modified food and feed, as provided for in Article 28 of the Regulation, regarding ACS-BNØØ4-7, ACS-BNØØ2-5 and the hybrid combination ACS-BNØØ4-7xACS-BNØØ2-5 oilseed rape shall be modified in order to take account of this Decision.

Article 4

This Decision is addressed to Bayer CropScience AG, Alfred-Nobel-Str. 50, D-40789 Monheim am Rhein, Germany.

Done at Brussels, 25 April 2007.

For the Commission

Markos KYPRIANOU

Member of the Commission

---

(1)  OJ L 268, 18.10.2003, p. 1. Regulation as amended by Commission Regulation (EC) of the European Parliament and of the Council No 1981/2006 (OJ L 368, 23.12.2006, p. 99).

1

(2)  OJ L 117, 8.5.1990, p. 15. Directive as repealed by Directive 2001/18/EC (OJ L 106, 17.4.2001, p. 1).

2

(3)  OJ L 164, 21.6.1997, p. 40.

3

(4)  OJ L 43, 14.2.1997, p. 1. Regulation last modified by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

4

---

ANNEX

Measures to be complied with by the notifier in order to ensure effective withdrawal from the market of seeds of hybrid oilseed rape ACS-BNØØ4-7xACS-BNØØ2-5 for the purpose of cultivation

| (a) | Inform commercial operators in the Community of the commercial and legal status of the seed. |
| --- | --- |

(a)

Inform commercial operators in the Community of the commercial and legal status of the seed.

| (b) | Recall remaining commercial seed stock held by operators. |
| --- | --- |

(b)

Recall remaining commercial seed stock held by operators.

| (c) | Destroy remaining commercial seed stock. |
| --- | --- |

(c)

Destroy remaining commercial seed stock.

| (d) | Conclude product discontinuation agreements with third parties instructing them to either send back seed or to verify and attest that the seed has been destroyed. |
| --- | --- |

(d)

Conclude product discontinuation agreements with third parties instructing them to either send back seed or to verify and attest that the seed has been destroyed.

| (e) | Undertake all necessary steps for the deregistration of registered varieties of the seed from the national seed catalogues. |
| --- | --- |

(e)

Undertake all necessary steps for the deregistration of registered varieties of the seed from the national seed catalogues.

| (f) | Implement an in-house program to avoid presence of the event in breeding and seed production. |
| --- | --- |

(f)

Implement an in-house program to avoid presence of the event in breeding and seed production.

---

| 5.5.2007 | EN | Official Journal of the European Union | L 117/23 |
| --- | --- | --- | --- |

5.5.2007

EN

Official Journal of the European Union

L 117/23

---

COMMISSION DECISION

of 25 April 2007

on the withdrawal from the market of Topas 19/2 (ACS-BNØØ7-1) oilseed rape and its derived products

(notified under document number C(2007) 1809)

(Only the German text is authentic)

(2007/307/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 the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Article 8(6) and 20(6) thereof,

Whereas:

| (1) | Seeds of oilseed rape (Brassica napus L. spp. oleifera) derived from traditional breeding crosses between non-genetically modified oilseed rape and a line resulting from transformation event Topas 19/2 (ACS-BNØØ7-1) have been granted consent pursuant to Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (2) by Commission Decision 98/291/EC of 22 April 1998 concerning the placing on the market of genetically modified spring swede rape (Brassica napus L. ssp oleifera) pursuant to Council Directive 90/220/EEC (3) for handling in the environment during import and before and during storage and processing. Directive 90/220/EEC has been recast and repealed by Directive 2001/18/EC. |
| --- | --- |

(1)

Seeds of oilseed rape (Brassica napus L. spp. oleifera) derived from traditional breeding crosses between non-genetically modified oilseed rape and a line resulting from transformation event Topas 19/2 (ACS-BNØØ7-1) have been granted consent pursuant to Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (2) by Commission Decision 98/291/EC of 22 April 1998 concerning the placing on the market of genetically modified spring swede rape (Brassica napus L. ssp oleifera) pursuant to Council Directive 90/220/EEC (3) for handling in the environment during import and before and during storage and processing. Directive 90/220/EEC has been recast and repealed by Directive 2001/18/EC.

| (2) | The consent was based on the opinion of 10 February 1998 of the Scientific Committee on Plants established by Commission Decision 97/579/EC (4). |
| --- | --- |

(2)

The consent was based on the opinion of 10 February 1998 of the Scientific Committee on Plants established by Commission Decision 97/579/EC (4).

| (3) | Processed oil from seeds of oilseed rape ACS-BNØØ7-1 and all conventional crosses was placed on the market in accordance with Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (5). |
| --- | --- |

(3)

Processed oil from seeds of oilseed rape ACS-BNØØ7-1 and all conventional crosses was placed on the market in accordance with Article 5 of Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (5).

| (4) | ACS-BNØØ7-1 oilseed rape and its derived products have subsequently been notified by Bayer CropScience AG (hereafter the notifier) as existing products under Article 8(1)(a) and Article 20(1) of Regulation (EC) No 1829/2003 (hereafter the Regulation) and entered in the Community Register of genetically modified food and feed. The scope of the notification covered food (processed oil) produced from seeds of oilseed rape ACS-BNØØ7-1 and all conventional crosses as well as feed containing or consisting of or produced from ACS-BNØØ7-1 oilseed rape for the placing on the market of the product or handling in the environment during import and before and during storage and processing. |
| --- | --- |

(4)

ACS-BNØØ7-1 oilseed rape and its derived products have subsequently been notified by Bayer CropScience AG (hereafter the notifier) as existing products under Article 8(1)(a) and Article 20(1) of Regulation (EC) No 1829/2003 (hereafter the Regulation) and entered in the Community Register of genetically modified food and feed. The scope of the notification covered food (processed oil) produced from seeds of oilseed rape ACS-BNØØ7-1 and all conventional crosses as well as feed containing or consisting of or produced from ACS-BNØØ7-1 oilseed rape for the placing on the market of the product or handling in the environment during import and before and during storage and processing.

| (5) | The notifier of oilseed rape ACS-BNØØ7-1, in a letter to the Commission dated 15 November 2005, indicated that varieties containing this event were no longer offered for sale on a global basis and that all inventory seed were recalled and destroyed after the 2003 sales season. |
| --- | --- |

(5)

The notifier of oilseed rape ACS-BNØØ7-1, in a letter to the Commission dated 15 November 2005, indicated that varieties containing this event were no longer offered for sale on a global basis and that all inventory seed were recalled and destroyed after the 2003 sales season.

| (6) | The notifier has further indicated to the Commission that it has no intention to submit an application for renewal of the authorisation of ACS-BNØØ7-1 oilseed rape under the Regulation in accordance with the first subparagraph of Article 8(4), Article 11, Article 20(4) and Article 23 respectively. Therefore ACS-BNØØ7-1 oilseed rape and its derived products cannot be placed on the market in the Community after 18 April 2007. |
| --- | --- |

(6)

The notifier has further indicated to the Commission that it has no intention to submit an application for renewal of the authorisation of ACS-BNØØ7-1 oilseed rape under the Regulation in accordance with the first subparagraph of Article 8(4), Article 11, Article 20(4) and Article 23 respectively. Therefore ACS-BNØØ7-1 oilseed rape and its derived products cannot be placed on the market in the Community after 18 April 2007.

| (7) | Measures to ensure effective withdrawal from the market of seeds of oilseed rape ACS-BNØØ7-1 for the purpose of cultivation are not necessary since these seeds could never be legally placed on the market in the Community. Since the notifier has stopped selling seeds of oilseed rape ACS-BNØØ7-1 after the 2003 planting season, stocks of products derived from ACS-BNØØ7-1 oilseed rape have been used up and are not expected to be present on the market after 18 April 2007. However, minute traces of ACS-BNØØ7-1 oilseed rape might remain present in food or feed products for a certain period of time. |
| --- | --- |

(7)

Measures to ensure effective withdrawal from the market of seeds of oilseed rape ACS-BNØØ7-1 for the purpose of cultivation are not necessary since these seeds could never be legally placed on the market in the Community. Since the notifier has stopped selling seeds of oilseed rape ACS-BNØØ7-1 after the 2003 planting season, stocks of products derived from ACS-BNØØ7-1 oilseed rape have been used up and are not expected to be present on the market after 18 April 2007. However, minute traces of ACS-BNØØ7-1 oilseed rape might remain present in food or feed products for a certain period of time.

| (8) | For reasons of legal certainty, it is therefore necessary to provide for a transitional period of time within which food and feed products may contain such material without being considered to be in breach of Article 4(2) or Article 16(2) of the Regulation where this presence is adventitious or technically unavoidable. |
| --- | --- |

(8)

For reasons of legal certainty, it is therefore necessary to provide for a transitional period of time within which food and feed products may contain such material without being considered to be in breach of Article 4(2) or Article 16(2) of the Regulation where this presence is adventitious or technically unavoidable.

| (9) | The tolerated level and the period of time should be set taking into account the time needed until the effective withdrawal from the market of the seeds produces its effects throughout the food and feed chain. In all cases, the tolerated level shall remain below the labelling and traceability threshold of no higher than 0,9 % provided for by the Regulation for the adventitious or technically unavoidable presence of GM material in food and feed. |
| --- | --- |

(9)

The tolerated level and the period of time should be set taking into account the time needed until the effective withdrawal from the market of the seeds produces its effects throughout the food and feed chain. In all cases, the tolerated level shall remain below the labelling and traceability threshold of no higher than 0,9 % provided for by the Regulation for the adventitious or technically unavoidable presence of GM material in food and feed.

| (10) | The entries in the Community Register of genetically modified food and feed, as provided for in Article 28 of the Regulation, regarding ACS-BNØØ7-1 oilseed rape should be modified in order to take account of this Decision. |
| --- | --- |

(10)

The entries in the Community Register of genetically modified food and feed, as provided for in Article 28 of the Regulation, regarding ACS-BNØØ7-1 oilseed rape should be modified in order to take account of this Decision.

| (11) | The notifier has been consulted on the measures provided for in this Decision. |
| --- | --- |

(11)

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

| (12) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(12)

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 presence of material which contains, consists of or is produced from ACS-BNØØ7-1 oilseed rape in food or feed products notified under Article 8(1)(a) and Article 20(1) of the Regulation shall be tolerated until five years after the date of notification of this Decision:

| (a) | provided that this presence is adventitious or technically unavoidable; and |
| --- | --- |

(a)

provided that this presence is adventitious or technically unavoidable; and

| (b) | in a proportion no higher than 0,9 %. |
| --- | --- |

(b)

in a proportion no higher than 0,9 %.

Article 2

The entries in the Community Register of genetically modified food and feed, as provided for in Article 28 of the Regulation, regarding ACS-BNØØ7-1 oilseed rape shall be modified in order to take account of this Decision.

Article 3

This Decision is addressed to Bayer CropScience AG, Alfred-Nobel-Str. 50, D-40789 Monheim am Rhein, Germany.

Done at Brussels, 25 April 2007.

For the Commission

Markos KYPRIANOU

Member of the Commission

---

(1)  OJ L 268, 18.10.2003, p. 1. Regulation as amended by Commission Regulation (EC) No 1981/2006 (OJ L 368, 23.12.2006, p. 99).

1

(2)  OJ L 117, 8.5.1990, p. 15. Directive as repealed by Directive 2001/18/EC of the European Parliament and of the Council (OJ L 106, 17.4.2001, p. 1).

2

(3)  OJ L 131, 5.5.1998, p. 26.

3

(4)  OJ L 237, 28.8.1997, p. 18.

4

(5)  OJ L 43, 14.2.1997, p. 1. Regulation as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).

5

---

| 5.5.2007 | EN | Official Journal of the European Union | L 117/25 |
| --- | --- | --- | --- |

5.5.2007

EN

Official Journal of the European Union

L 117/25

---

COMMISSION DECISION

of 25 April 2007

on the withdrawal from the market of products derived from GA21xMON810 (MON-ØØØ21-9xMON-ØØ81Ø-6) maize

(notified under document number C(2007) 1810)

(Only the French and Dutch texts are authentic)

(2007/308/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 the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Article 8(6) and 20(6) thereof,

Whereas:

| (1) | Products derived from GA21xMON810 (MON-ØØØ21-9xMON-ØØ81Ø-6) maize have been notified as existing products by Monsanto Europe S.A (hereafter the notifier) under Article 8(1)(b) and Article 20(1)(b) of Regulation (EC) No 1829/2003 (hereafter the Regulation) and entered in the Community Register of genetically modified food and feed. The scope of the notification covered food additives, feed materials and feed additives produced from MON-ØØØ21-9xMON-ØØ81Ø-6 maize. |
| --- | --- |

(1)

Products derived from GA21xMON810 (MON-ØØØ21-9xMON-ØØ81Ø-6) maize have been notified as existing products by Monsanto Europe S.A (hereafter the notifier) under Article 8(1)(b) and Article 20(1)(b) of Regulation (EC) No 1829/2003 (hereafter the Regulation) and entered in the Community Register of genetically modified food and feed. The scope of the notification covered food additives, feed materials and feed additives produced from MON-ØØØ21-9xMON-ØØ81Ø-6 maize.

| (2) | No consent for placing on the market of seeds from MON-ØØØ21-9xMON-ØØ81Ø-6 maize has been granted in the Community. The notifier of MON-ØØØ21-9xMON-ØØ81Ø-6 maize, in a letter to the Commission dated 1 March 2007, indicated that 2005 was the last year of approved commercial sales of seeds of MON-ØØØ21-9xMON-ØØ81Ø-6 maize on a global basis. |
| --- | --- |

(2)

No consent for placing on the market of seeds from MON-ØØØ21-9xMON-ØØ81Ø-6 maize has been granted in the Community. The notifier of MON-ØØØ21-9xMON-ØØ81Ø-6 maize, in a letter to the Commission dated 1 March 2007, indicated that 2005 was the last year of approved commercial sales of seeds of MON-ØØØ21-9xMON-ØØ81Ø-6 maize on a global basis.

| (3) | The notifier has further indicated to the Commission that it has no intention to submit an application for renewal of the authorisation of products derived from MON-ØØØ21-9xMON-ØØ81Ø-6 maize under the Regulation in accordance with the second sub-paragraph of Article 8(4), Article 11, the second sub-paragraph of Article 20(4), and Article 23 respectively. Therefore products derived from MON-ØØØ21-9xMON-ØØ81Ø-6 maize cannot be placed on the market in the Community after 18 April 2007. |
| --- | --- |

(3)

The notifier has further indicated to the Commission that it has no intention to submit an application for renewal of the authorisation of products derived from MON-ØØØ21-9xMON-ØØ81Ø-6 maize under the Regulation in accordance with the second sub-paragraph of Article 8(4), Article 11, the second sub-paragraph of Article 20(4), and Article 23 respectively. Therefore products derived from MON-ØØØ21-9xMON-ØØ81Ø-6 maize cannot be placed on the market in the Community after 18 April 2007.

| (4) | Measures to ensure effective withdrawal from the market of seeds of MON-ØØØ21-9xMON-ØØ81Ø-6 maize are not necessary since these seeds could never be legally placed on the market in the Community. Since the notifier has stopped selling seeds of MON-ØØØ21-9xMON-ØØ81Ø-6 maize after the 2005 planting season, stocks of products derived from MON-ØØØ21-9xMON-ØØ81Ø-6 maize have been used up and are not expected to be present on the market after 18 April 2007. However, minute traces of MON-ØØØ21-9xMON-ØØ81Ø-6 maize might remain present in food or feed products for a certain period of time. |
| --- | --- |

(4)

Measures to ensure effective withdrawal from the market of seeds of MON-ØØØ21-9xMON-ØØ81Ø-6 maize are not necessary since these seeds could never be legally placed on the market in the Community. Since the notifier has stopped selling seeds of MON-ØØØ21-9xMON-ØØ81Ø-6 maize after the 2005 planting season, stocks of products derived from MON-ØØØ21-9xMON-ØØ81Ø-6 maize have been used up and are not expected to be present on the market after 18 April 2007. However, minute traces of MON-ØØØ21-9xMON-ØØ81Ø-6 maize might remain present in food or feed products for a certain period of time.

| (5) | For reasons of legal certainty, it is therefore necessary to provide for a transitional period of time within which food and feed products may contain such material without being considered to be in breach of Article 4(2) or Article 16(2) of the Regulation where this presence is adventitious or technically unavoidable. |
| --- | --- |

(5)

For reasons of legal certainty, it is therefore necessary to provide for a transitional period of time within which food and feed products may contain such material without being considered to be in breach of Article 4(2) or Article 16(2) of the Regulation where this presence is adventitious or technically unavoidable.

| (6) | The tolerated level and the period of time should be set taking into account the time needed until the non-availability of the seeds produces its effects throughout the food and feed chain. In all cases, the tolerated level shall remain below the labelling and traceability threshold of no higher than 0,9 % provided for by the Regulation for the adventitious or technically unavoidable presence of GM material in food and feed. |
| --- | --- |

(6)

The tolerated level and the period of time should be set taking into account the time needed until the non-availability of the seeds produces its effects throughout the food and feed chain. In all cases, the tolerated level shall remain below the labelling and traceability threshold of no higher than 0,9 % provided for by the Regulation for the adventitious or technically unavoidable presence of GM material in food and feed.

| (7) | The entries in the Community Register of genetically modified food and feed, as provided for in Article 28 of the Regulation, regarding MON-ØØØ21-9xMON-ØØ81Ø-6 maize should be modified in order to take account of this Decision. |
| --- | --- |

(7)

The entries in the Community Register of genetically modified food and feed, as provided for in Article 28 of the Regulation, regarding MON-ØØØ21-9xMON-ØØ81Ø-6 maize should be modified in order to take account of this Decision.

| (8) | The notifier has been consulted on the measures provided for in this Decision. |
| --- | --- |

(8)

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

| (9) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(9)

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

The presence of material produced from MON-ØØØ21-9xMON-ØØ81Ø-6 maize in food or feed products notified under Article 8(1)(b) and Article 20(1)(b) of the Regulation shall be tolerated until five years after the date of notification of this Decision:

| (a) | provided that this presence is adventitious or technically unavoidable; and |
| --- | --- |

(a)

provided that this presence is adventitious or technically unavoidable; and

| (b) | in a proportion no higher than 0,9 %. |
| --- | --- |

(b)

in a proportion no higher than 0,9 %.

Article 2

The entries in the Community Register of genetically modified food and feed, as provided for in Article 28 of the Regulation, regarding MON-ØØØ21-9xMON-ØØ81Ø-6 maize shall be modified in order to take account of this Decision.

Article 3

This Decision is addressed to Monsanto Europe S.A., Scheldelaan 460, Haven 627, B–2040 Antwerp, representing Monsanto Company, United States of America.

Done at Brussels, 25 April 2007.

For the Commission

Markos KYPRIANOU

Member of the Commission

---

(1)  OJ L 268, 18.10.2003, p. 1. Regulation as amended by Commission Regulation (EC) No 1981/2006 (OJ L 368, 23.12.2006, p. 99).

1

---

| 5.5.2007 | EN | Official Journal of the European Union | L 117/27 |
| --- | --- | --- | --- |

5.5.2007

EN

Official Journal of the European Union

L 117/27

---

COMMISSION DECISION

of 27 April 2007

on a financial contribution from the Community towards emergency measures to combat avian influenza in Hungary in 2006

(notified under document number C(2007) 1818)

(Only the Hungarian text is authentic)

(2007/309/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (1), and in particular Article 3(3) and 3a(1) thereof,

Whereas:

| (1) | Decision 90/424/EEC lays down the procedures governing the Community’s financial contribution towards specific veterinary measures, including emergency measures. Decision 90/424/EEC, as amended by Decision 2006/53/EC (2), provides for a Community financial contribution to Member States to cover certain costs involved in taking measures to eradicate avian influenza. |
| --- | --- |

(1)

Decision 90/424/EEC lays down the procedures governing the Community’s financial contribution towards specific veterinary measures, including emergency measures. Decision 90/424/EEC, as amended by Decision 2006/53/EC (2), provides for a Community financial contribution to Member States to cover certain costs involved in taking measures to eradicate avian influenza.

| (2) | Outbreaks of avian influenza occurred in Hungary in 2006. The emergence of that disease represents a serious risk to the Community’s livestock population. Under Article 3a(2) of Decision 90/424/EEC, Hungary took measures to combat those outbreaks. |
| --- | --- |

(2)

Outbreaks of avian influenza occurred in Hungary in 2006. The emergence of that disease represents a serious risk to the Community’s livestock population. Under Article 3a(2) of Decision 90/424/EEC, Hungary took measures to combat those outbreaks.

| (3) | The payment of a Community financial contribution must be made subject to the condition that the planned measures were actually implemented and that the competent authorities provided all the necessary information to the Commission within certain deadlines. |
| --- | --- |

(3)

The payment of a Community financial contribution must be made subject to the condition that the planned measures were actually implemented and that the competent authorities provided all the necessary information to the Commission within certain deadlines.

| (4) | Commission Regulation (EC) No 349/2005 of 28 February 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), following the amendment of Decision 90/424/EEC by Decision 2006/53/EC, no longer covers avian influenza. It is therefore necessary to expressly provide in the present Decision that the granting of a financial contribution to Hungary is subject to compliance with certain rules laid down in Regulation (EC) No 349/2005. |
| --- | --- |

(4)

Commission Regulation (EC) No 349/2005 of 28 February 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), following the amendment of Decision 90/424/EEC by Decision 2006/53/EC, no longer covers avian influenza. It is therefore necessary to expressly provide in the present Decision that the granting of a financial contribution to Hungary is subject to compliance with certain rules laid down in Regulation (EC) No 349/2005.

| (5) | Article 3a(3) of Decision 90/424/EEC provides that the Community financial contribution is to be 50 % of the eligible costs incurred by the Member State. |
| --- | --- |

(5)

Article 3a(3) of Decision 90/424/EEC provides that the Community financial contribution is to be 50 % of the eligible costs incurred by the Member State.

| (6) | Hungary has fully complied with its technical and administrative obligations as set out in Articles 3(3) and 3a(2) of Decision 90/424/EEC. Hungary has forwarded to the Commission information on the costs incurred in the framework of this outbreak on 27 October 2006. |
| --- | --- |

(6)

Hungary has fully complied with its technical and administrative obligations as set out in Articles 3(3) and 3a(2) of Decision 90/424/EEC. Hungary has forwarded to the Commission information on the costs incurred in the framework of this outbreak on 27 October 2006.

| (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

Financial contribution from the Community

1.   A financial contribution from the Community may be granted to Hungary towards the costs incurred by that Member State in taking the measures referred to in Article 3a(2) of Decision 90/424/EEC to combat avian influenza in 2006.

The financial contribution shall be 50 % of the costs incurred that are eligible for Community funding.

2.   For the purposes of this Decision, Articles 2 to 5 and Articles 7 and 8 and Article 9(2), (3) and (4) and Article 10 of Regulation (EC) No 349/2005 shall apply mutatis mutandis.

Article 2

Payment arrangements

A first tranche of EUR 1 000 000 shall be paid as part of the Community financial contribution provided for in Article 1.

Article 3

Addressee

This Decision is addressed to the Republic of Hungary.

Done at Brussels, 27 April 2007.

For the Commission

Markos KYPRIANOU

Member of the Commission

---

(1)  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).

1

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

2

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

3

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| 5.5.2007 | EN | Official Journal of the European Union | L 117/29 |
| --- | --- | --- | --- |

5.5.2007

EN

Official Journal of the European Union

L 117/29

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COMMISSION DECISION

of 27 April 2007

on a financial contribution from the Community towards emergency measures to combat avian influenza in Denmark in 2006

(notified under document number C(2007) 1820)

(Only the Danish text is authentic)

(2007/310/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (1), and in particular Article 3(3) and 3a(1) thereof,

Whereas:

| (1) | Decision 90/424/EEC lays down the procedures governing the Community’s financial contribution towards specific veterinary measures, including emergency measures. Decision 90/424/EEC, as amended by Decision 2006/53/EC (2), provides for a Community financial contribution to Member States to cover certain costs involved in taking measures to eradicate avian influenza. |
| --- | --- |

(1)

Decision 90/424/EEC lays down the procedures governing the Community’s financial contribution towards specific veterinary measures, including emergency measures. Decision 90/424/EEC, as amended by Decision 2006/53/EC (2), provides for a Community financial contribution to Member States to cover certain costs involved in taking measures to eradicate avian influenza.

| (2) | Outbreaks of avian influenza occurred in Denmark in 2006. The emergence of that disease represents a serious risk to the Community’s livestock population. Under Article 3a(2) of Decision 90/424/EEC, Denmark took measures to combat those outbreaks. |
| --- | --- |

(2)

Outbreaks of avian influenza occurred in Denmark in 2006. The emergence of that disease represents a serious risk to the Community’s livestock population. Under Article 3a(2) of Decision 90/424/EEC, Denmark took measures to combat those outbreaks.

| (3) | The payment of a Community financial contribution must be made subject to the condition that the planned measures were actually implemented and that the competent authorities provided all the necessary information to the Commission within certain deadlines. |
| --- | --- |

(3)

The payment of a Community financial contribution must be made subject to the condition that the planned measures were actually implemented and that the competent authorities provided all the necessary information to the Commission within certain deadlines.

| (4) | Commission Regulation (EC) No 349/2005 of 28 February 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), following the amendment of Decision 90/424/EEC by Decision 2006/53/EC, no longer covers avian influenza. It is therefore necessary to expressly provide in the present Decision that the granting of a financial contribution to Denmark is subject to compliance with certain rules laid down in Regulation (EC) No 349/2005. |
| --- | --- |

(4)

Commission Regulation (EC) No 349/2005 of 28 February 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), following the amendment of Decision 90/424/EEC by Decision 2006/53/EC, no longer covers avian influenza. It is therefore necessary to expressly provide in the present Decision that the granting of a financial contribution to Denmark is subject to compliance with certain rules laid down in Regulation (EC) No 349/2005.

| (5) | Article 3a(3) of Decision 90/424/EEC provides that the Community financial contribution is to be 50 % of the eligible costs incurred by the Member State. |
| --- | --- |

(5)

Article 3a(3) of Decision 90/424/EEC provides that the Community financial contribution is to be 50 % of the eligible costs incurred by the Member State.

| (6) | Denmark has fully complied with its technical and administrative obligations as set out in Articles 3(3) and 3a(2) of Decision 90/424/EEC. Denmark has forwarded to the Commission information on the costs incurred in the framework of this outbreak on 8 June 2006 and thereafter continued to provide all necessary information on costs of compensation and operational expenditure. |
| --- | --- |

(6)

Denmark has fully complied with its technical and administrative obligations as set out in Articles 3(3) and 3a(2) of Decision 90/424/EEC. Denmark has forwarded to the Commission information on the costs incurred in the framework of this outbreak on 8 June 2006 and thereafter continued to provide all necessary information on costs of compensation and operational expenditure.

| (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

Financial contribution from the Community

1.   A financial contribution from the Community may be granted to Denmark towards the costs incurred by that Member State in taking the measures referred to in Article 3a(2) of Decision 90/424/EEC to combat avian influenza in 2006.

The financial contribution shall be 50 % of the costs incurred that are eligible for Community funding.

2.   For the purposes of this Decision, Articles 2 to 5 and Articles 7 and 8 and Article 9(2), (3) and (4) and Article 10 of Regulation (EC) No 349/2005 shall apply mutatis mutandis.

Article 2

Addressee

This Decision is addressed to the Kingdom of Denmark.

Done at Brussels, 27 April 2007.

For the Commission

Markos KYPRIANOU

Member of the Commission

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(1)  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).

1

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

2

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

3

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Corrigenda

| 5.5.2007 | EN | Official Journal of the European Union | L 117/31 |
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5.5.2007

EN

Official Journal of the European Union

L 117/31

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Corrigendum to Council Decision 2006/930/EC of 28 November 2006 concerning the conclusion of the Agreement in the form of an Exchange of Letters between the European Community and the Argentine Republic relating to the modification of concessions in the schedules of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic in the course of accession to the European Community

(
  Official Journal of the European Union L 355 of 15 December 2006
  )

On page 91, the following articles shall be inserted:

‘Article 1a

The Commission shall adopt the detailed rules for implementing the Agreement in the form of an Exchange of Letters in accordance with the procedure laid down in Article 1b(2) of this Decision.

Article 1b

1.   The Commission shall be assisted by the Management Committee for Cereals instituted by Article 25 of Regulation (EC) No 1784/2003 of 29 September 2003 on the common organisation of the market in cereals (1) or the relevant committee instituted by the corresponding Article of the Regulation for the common market organisation for the product concerned.

2.   Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC (2) shall apply.

The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month.

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(1)  OJ L 270, 21.10.2003, p. 78. Regulation as amended by Commission Regulation (EC) No 1154/2005 (OJ L 187, 19.7.2005, p. 11).

1

(2)  OJ L 184, 17.7.1999, p. 23.’

2

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| 5.5.2007 | EN | Official Journal of the European Union | L 117/31 |
| --- | --- | --- | --- |

5.5.2007

EN

Official Journal of the European Union

L 117/31

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Corrigendum to Council Decision 2006/963/EC of 18 December 2006 concerning the conclusion of the Agreement in the form of an Exchange of Letters between the European Community and Brazil relating to the modification of concessions in the schedules of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic in the course of accession to the European Community

(
  Official Journal of the European Union L 397 of 30 December 2006
  )

On page 10, the following articles shall be inserted:

‘Article 1a

The Commission shall adopt the detailed rules for implementing the Agreement in the form of an Exchange of Letters in accordance with the procedure laid down in Article 1b(2) of this Decision.

Article 1b

1.   The Commission shall be assisted by the Management Committee for Cereals instituted by Article 25 of Regulation (EC) No 1784/2003 of 29 September 2003 on the common organisation of the market in cereals (1) or the relevant committee instituted by the corresponding Article of the Regulation for the common market organisation for the product concerned.

2.   Where reference is made to this paragraph, Articles 4 and 7 of Decision 1999/468/EC (2) shall apply.

The period laid down in Article 4(3) of Decision 1999/468/EC shall be set at one month.

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(1)  OJ L 270, 21.10.2003, p. 78. Regulation as amended by Commission Regulation (EC) No 1154/2005 (OJ L 187, 19.7.2005, p. 11).

1

(2)  OJ L 184, 17.7.1999, p. 23.’

2

---