# Official Journal L 87/2008

| | ISSN 1725-2555 |
| --- | --- |
| Official Journal
  of the European Union | L 87 |
| | |
| English edition | Legislation | Volume 5129 March 2008 |

ISSN 1725-2555

Official Journal

of the European Union

L 87

English edition

Legislation

Volume 5129 March 2008

---

| Contents | | I   Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | | Commission Regulation (EC) No 286/2008 of 28 March 2008 establishing the standard import values for determining the entry price of certain fruit and vegetables | 1 |
| | * | Commission Regulation (EC) No 287/2008 of 28 March 2008 on the extension of the period of validity of referred to in Article 2c(3) of Regulation (EC) No 1702/2003 (
  1
  ) | 3 |
| | | DIRECTIVES |
| | * | Commission Directive 2008/40/EC of 28 March 2008 amending Council Directive 91/414/EEC to include amidosulfuron and nicosulfuron as active substances (
  1
  ) | 5 |

Contents

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

page

REGULATIONS

Commission Regulation (EC) No 286/2008 of 28 March 2008 establishing the standard import values for determining the entry price of certain fruit and vegetables

1

*

Commission Regulation (EC) No 287/2008 of 28 March 2008 on the extension of the period of validity of referred to in Article 2c(3) of Regulation (EC) No 1702/2003 (
  1
  )

1

3

DIRECTIVES

*

Commission Directive 2008/40/EC of 28 March 2008 amending Council Directive 91/414/EEC to include amidosulfuron and nicosulfuron as active substances (
  1
  )

1

5

| | | II   Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory |
| --- | --- | --- |
| | | DECISIONS |
| | | Council |
| | | 2008/274/EC |
| | * | Council Decision of 17 March 2008 on the conclusion of the Agreement between the European Community and the Kingdom of Morocco on certain aspects of air services | 9 |
| | | 2008/275/EC |
| | * | Council Decision of 17 March 2008 on the conclusion of a Protocol amending Annexes I and II to the Agreement between the European Community and the Kingdom of Morocco on certain aspects of air services, in order to take account of the accession to the European Union of the Republic of Bulgaria and Romania | 10 |
| Protocol amending Annexes I and II to the Agreement between the European Community and the Kingdom of Morocco on certain aspects of air services | 11 |
| | | Commission |
| | | 2008/276/EC |
| | * | Commission Decision of 17 March 2008 amending Decision 2005/338/EC in order to prolong the validity of the ecological criteria for the award of the Community eco-label to campsite service
  (notified under document number C(2008) 1128)

   (
  1
  ) | 12 |
| | | 2008/277/EC |
| | * | Commission Decision of 26 March 2008 amending Decision 2001/405/EC in order to prolong the validity of the ecological criteria for the award of the Community eco-label to tissue paper products
  (notified under document number C(2008) 1222)

   (
  1
  ) | 14 |
| | | 2008/278/EC |
| | * | Commission Decision of 26 March 2008 amending Decision 2006/589/EC as regards aviglycine HCl
  (notified under document number C(2008) 1071)

   (
  1
  ) | 15 |
| | | 2008/279/EC |
| | * | Commission Decision of 28 March 2008 repealing Decision 2006/69/EC authorising the placing on the market of foods and food ingredients produced from genetically modified Roundup Ready maize line GA21 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council
  (notified under document number C(2008) 1116) | 17 |
| | | 2008/280/EC |
| | * | Commission Decision of 28 March 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
  (notified under document number C(2008) 1112) | 19 |

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

DECISIONS

Council

2008/274/EC

*

Council Decision of 17 March 2008 on the conclusion of the Agreement between the European Community and the Kingdom of Morocco on certain aspects of air services

9

2008/275/EC

*

Council Decision of 17 March 2008 on the conclusion of a Protocol amending Annexes I and II to the Agreement between the European Community and the Kingdom of Morocco on certain aspects of air services, in order to take account of the accession to the European Union of the Republic of Bulgaria and Romania

10

Protocol amending Annexes I and II to the Agreement between the European Community and the Kingdom of Morocco on certain aspects of air services

11

Commission

2008/276/EC

*

Commission Decision of 17 March 2008 amending Decision 2005/338/EC in order to prolong the validity of the ecological criteria for the award of the Community eco-label to campsite service
  (notified under document number C(2008) 1128)

   (
  1
  )

(notified under document number C(2008) 1128)

1

12

2008/277/EC

*

Commission Decision of 26 March 2008 amending Decision 2001/405/EC in order to prolong the validity of the ecological criteria for the award of the Community eco-label to tissue paper products
  (notified under document number C(2008) 1222)

   (
  1
  )

(notified under document number C(2008) 1222)

1

14

2008/278/EC

*

Commission Decision of 26 March 2008 amending Decision 2006/589/EC as regards aviglycine HCl
  (notified under document number C(2008) 1071)

   (
  1
  )

(notified under document number C(2008) 1071)

1

15

2008/279/EC

*

Commission Decision of 28 March 2008 repealing Decision 2006/69/EC authorising the placing on the market of foods and food ingredients produced from genetically modified Roundup Ready maize line GA21 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council
  (notified under document number C(2008) 1116)

(notified under document number C(2008) 1116)

17

2008/280/EC

*

Commission Decision of 28 March 2008 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council
  (notified under document number C(2008) 1112)

(notified under document number C(2008) 1112)

19

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

| 29.3.2008 | EN | Official Journal of the European Union | L 87/1 |
| --- | --- | --- | --- |

29.3.2008

EN

Official Journal of the European Union

L 87/1

---

COMMISSION REGULATION (EC) No 286/2008

of 28 March 2008

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

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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

Whereas:

| (1) | Regulation (EC) No 1580/2007 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in the Annex thereto. |
| --- | --- |

(1)

Regulation (EC) No 1580/2007 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in 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 138 of Regulation (EC) No 1580/2007 shall be fixed as indicated in the Annex hereto.

Article 2

This Regulation shall enter into force on 29 March 2008.

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

Done at Brussels, 28 March 2008.

For the Commission

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

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

1

---

ANNEX

to Commission Regulation of 28 March 2008 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 | JO | 64,0 |
| MA | 52,9 |
| TN | 125,1 |
| TR | 123,9 |
| ZZ | 91,5 |
| 0707 00 05 | JO | 178,8 |
| MA | 69,9 |
| MK | 99,4 |
| TR | 174,8 |
| ZZ | 130,7 |
| 0709 90 70 | MA | 56,4 |
| TR | 118,3 |
| ZZ | 87,4 |
| 0805 10 20 | EG | 46,1 |
| IL | 58,2 |
| MA | 58,3 |
| TN | 54,0 |
| TR | 71,2 |
| ZZ | 57,6 |
| 0805 50 10 | IL | 119,0 |
| TR | 124,3 |
| ZA | 147,5 |
| ZZ | 130,3 |
| 0808 10 80 | AR | 92,1 |
| BR | 80,7 |
| CA | 103,3 |
| CL | 95,0 |
| CN | 93,3 |
| MK | 42,9 |
| US | 121,7 |
| UY | 60,1 |
| ZA | 62,1 |
| ZZ | 83,5 |
| 0808 20 50 | AR | 76,1 |
| CL | 75,0 |
| CN | 53,0 |
| ZA | 95,8 |
| ZZ | 75,0 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

JO

64,0

MA

52,9

TN

125,1

TR

123,9

ZZ

91,5

0707 00 05

JO

178,8

MA

69,9

MK

99,4

TR

174,8

ZZ

130,7

0709 90 70

MA

56,4

TR

118,3

ZZ

87,4

0805 10 20

EG

46,1

IL

58,2

MA

58,3

TN

54,0

TR

71,2

ZZ

57,6

0805 50 10

IL

119,0

TR

124,3

ZA

147,5

ZZ

130,3

0808 10 80

AR

92,1

BR

80,7

CA

103,3

CL

95,0

CN

93,3

MK

42,9

US

121,7

UY

60,1

ZA

62,1

ZZ

83,5

0808 20 50

AR

76,1

CL

75,0

CN

53,0

ZA

95,8

ZZ

75,0

---

(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’.

---

| 29.3.2008 | EN | Official Journal of the European Union | L 87/3 |
| --- | --- | --- | --- |

29.3.2008

EN

Official Journal of the European Union

L 87/3

---

COMMISSION REGULATION (EC) No 287/2008

of 28 March 2008

on the extension of the period of validity of referred to in Article 2c(3) of Regulation (EC) No 1702/2003

(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 1592/2002 of the European Parliament and of the Council of 15 July 2002 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency (1), and in particular Article 5 thereof,

Whereas:

| (1) | Aircraft falling within the scope of Article 2c of Commission Regulation (EC) No 1702/2003 (2) and meeting the specific airworthiness specifications laid down therein are to be issued by Member States restricted certificates of airworthiness allowing them to continue until 28 March 2008 the operations that they were entitled to perform on 28 March 2007. |
| --- | --- |

(1)

Aircraft falling within the scope of Article 2c of Commission Regulation (EC) No 1702/2003 (2) and meeting the specific airworthiness specifications laid down therein are to be issued by Member States restricted certificates of airworthiness allowing them to continue until 28 March 2008 the operations that they were entitled to perform on 28 March 2007.

| (2) | Article 2c(3) of Regulation (EC) No 1702/2003 provides that the Commission may extend the period of validity referred to in paragraph 2 of that Article by a maximum of 18 months, provided that a certification process for the type of aircraft concerned has been undertaken by the European Aviation Safety Agency (the Agency) before 28 March 2008 and that the Agency has determined that such process can be concluded within the additional period of validity. |
| --- | --- |

(2)

Article 2c(3) of Regulation (EC) No 1702/2003 provides that the Commission may extend the period of validity referred to in paragraph 2 of that Article by a maximum of 18 months, provided that a certification process for the type of aircraft concerned has been undertaken by the European Aviation Safety Agency (the Agency) before 28 March 2008 and that the Agency has determined that such process can be concluded within the additional period of validity.

| (3) | Pursuant to Article 2c(3) of Regulation (EC) No 1702/2003 the Agency issued a determination on 15 February 2008 to the effect that the conditions for extending the period of validity referred to in paragraph 2 of Article 2c of Regulation (EC) No 1702/2003 are met as regards certain types of aircraft. It notified its determination to the Commission on the same day. |
| --- | --- |

(3)

Pursuant to Article 2c(3) of Regulation (EC) No 1702/2003 the Agency issued a determination on 15 February 2008 to the effect that the conditions for extending the period of validity referred to in paragraph 2 of Article 2c of Regulation (EC) No 1702/2003 are met as regards certain types of aircraft. It notified its determination to the Commission on the same day.

| (4) | Specifically, in its determination the Agency states that it has received and accepted applications for the certification and/or validation of the type certificates issued by the certifying authorities of the ex-Soviet Union of two aircraft: the aeroplane of type Antonov AN-26, enabling it to also consider the certification of the aeroplane of type AN-26B, and the helicopter of the type Kamov-32A11BC, enabling it to also consider the certification of the helicopter of type Kamov-32A12. |
| --- | --- |

(4)

Specifically, in its determination the Agency states that it has received and accepted applications for the certification and/or validation of the type certificates issued by the certifying authorities of the ex-Soviet Union of two aircraft: the aeroplane of type Antonov AN-26, enabling it to also consider the certification of the aeroplane of type AN-26B, and the helicopter of the type Kamov-32A11BC, enabling it to also consider the certification of the helicopter of type Kamov-32A12.

| (5) | In its determination the Agency further concludes that it can complete the certification process of these aircraft types by 28 September 2009. |
| --- | --- |

(5)

In its determination the Agency further concludes that it can complete the certification process of these aircraft types by 28 September 2009.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Committee referred to in Article 54(3) of Regulation (EC) No 1592/2002, |
| --- | --- |

(6)

The measures provided for in this Regulation are in accordance with the opinion of the Committee referred to in Article 54(3) of Regulation (EC) No 1592/2002,

HAS ADOPTED THIS REGULATION:

Article 1

The period of validity referred to in paragraph 2 of Article 2c of Regulation (EC) No 1702/2003 is extended until 28 September 2009 with respect to the aeroplanes of type Antonov AN-26 and AN-26B and the helicopters of type Kamov-32A12 and Kamov-32A11BC.

Article 2

This Regulation shall enter into force on the 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, 28 March 2008.

For the Commission

Jacques BARROT

Vice-President

---

(1)  
  OJ L 240, 7.9.2002, p. 1. Regulation as last amended by Commission Regulation (EC) No 334/2007 (OJ L 88, 29.3.2007, p. 39).

1

(2)  
  OJ L 243, 27.9.2003, p. 6. Regulation as last amended by Regulation (EC) No 375/2007 (OJ L 94, 4.4.2007, p. 3).

2

---

DIRECTIVES

| 29.3.2008 | EN | Official Journal of the European Union | L 87/5 |
| --- | --- | --- | --- |

29.3.2008

EN

Official Journal of the European Union

L 87/5

---

COMMISSION DIRECTIVE 2008/40/EC

of 28 March 2008

amending Council Directive 91/414/EEC to include amidosulfuron and nicosulfuron as active substances

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,

Whereas:

| (1) | Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes amidosulfuron and nicosulfuron. |
| --- | --- |

(1)

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

| (2) | For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 1490/2002 for a range of uses proposed by the notifiers. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 10(1) of Regulation (EC) No 1490/2002. For amidosulfuron and nicosulfuron the rapporteur Member States were Austria and the United Kingdom and all relevant information was submitted on 31 May 2005 and 7 December 2005 respectively. |
| --- | --- |

(2)

For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 1490/2002 for a range of uses proposed by the notifiers. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 10(1) of Regulation (EC) No 1490/2002. For amidosulfuron and nicosulfuron the rapporteur Member States were Austria and the United Kingdom and all relevant information was submitted on 31 May 2005 and 7 December 2005 respectively.

| (3) | The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Commission on 22 January 2007 for amidosulfuron and nicosulfuron, in the format of the EFSA Scientific Reports (4). These reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 22 January 2008 in the format of the Commission review reports for amidosulfuron and nicosulfuron. |
| --- | --- |

(3)

The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Commission on 22 January 2007 for amidosulfuron and nicosulfuron, in the format of the EFSA Scientific Reports (4). These reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 22 January 2008 in the format of the Commission review reports for amidosulfuron and nicosulfuron.

| (4) | It has appeared from the various examinations made that plant protection products containing amidosulfuron and nicosulfuron may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive. |
| --- | --- |

(4)

It has appeared from the various examinations made that plant protection products containing amidosulfuron and nicosulfuron may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive.

| (5) | A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion. |
| --- | --- |

(5)

A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

| (6) | Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing amidosulfuron and nicosulfuron to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By way of derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC. |
| --- | --- |

(6)

Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing amidosulfuron and nicosulfuron to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By way of derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

| (7) | The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I. |
| --- | --- |

(7)

The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 (5) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.

| (8) | It is therefore appropriate to amend Directive 91/414/EEC accordingly. |
| --- | --- |

(8)

It is therefore appropriate to amend Directive 91/414/EEC accordingly.

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

(9)

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

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.

Article 2

Member States shall adopt and publish by 30 April 2009 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.

They shall apply those provisions from 1 May 2009.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

Article 3

1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing amidosulfuron and nicosulfuron as active substances by 30 April 2009.

By that date they shall in particular verify that the conditions in Annex I to that Directive relating to amidosulfuron and nicosulfuron are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.

2.   By way of derogation from paragraph 1, for each authorised plant protection product containing amidosulfuron and nicosulfuron as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 October 2008 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning amidosulfuron and nicosulfuron respectively. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.

Following that determination Member States shall:

| (a) | in the case of a product containing amidosulfuron and nicosulfuron as the only active substance, where necessary, amend or withdraw the authorisation by 31 October 2012 at the latest; or |
| --- | --- |

(a)

in the case of a product containing amidosulfuron and nicosulfuron as the only active substance, where necessary, amend or withdraw the authorisation by 31 October 2012 at the latest; or

| (b) | in the case of a product containing amidosulfuron and nicosulfuron as one of several active substances, where necessary, amend or withdraw the authorisation by 31 October 2012 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest. |
| --- | --- |

(b)

in the case of a product containing amidosulfuron and nicosulfuron as one of several active substances, where necessary, amend or withdraw the authorisation by 31 October 2012 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

Article 4

This Directive shall enter into force on 1 November 2008.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 28 March 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission

---

(1)  
  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/76/EC (OJ L 337, 21.12.2007, p. 100).

1

(2)  
  OJ L 55, 29.2.2000, p. 25. Regulation as last amended by Regulation (EC) No 1044/2003 (OJ L 151, 19.6.2003, p. 32).

2

(3)  
  OJ L 224, 21.8.2002, p. 23. Regulation as last amended by Regulation (EC) No 1095/2007 (OJ L 246, 21.9.2007, p. 19).

3

(4)  EFSA Scientific Report (2007) 116, 1-86, Conclusion regarding the peer review of the pesticide risk assessment of the active substance amidosulfuron (finalised 14 November 2007).

4

EFSA Scientific Report (2007) 120, 1-91, Conclusion regarding the peer review of the pesticide risk assessment of the active substance nicosulfuron (finalised 29 November 2007).

(5)  
  OJ L 366, 15.12.1992, p. 10. Regulation as last amended by Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 27).

5

---

ANNEX

The following entry shall be added at the end of the table in Annex I to Directive 91/414/EEC:

| No | Common name, identification numbers | IUPAC name | Purity (1) | Entry into force | Expiration of inclusion | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- |
| ‘175 | Amidosulfuron
  CAS No 120923-37-7
  CIPAC No 515 | 3-(4,6-dimethoxypyrimidin-2-yl)-1-(N-methyl-N-methylsulfonyl-aminosulfonyl)urea
  or
  1-(4,6-dimethoxypyrimidin-2-yl)-3-mesyl(methyl) sulfamoylurea | ≥ 970 g/kg | 1 January 2009 | 31 December 2018 | PART A
  Only uses as herbicide may be authorised.
  PART B
  In assessing applications to authorise plant protection products containing amidosulfuron for uses other than meadows and pasture, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
  For the implementation of the uniform principles of Annex VI, the conclusions of the review report on amidosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.
  In this overall assessment Member States must pay particular attention to:






  — | the protection of groundwater due to a potential for groundwater contamination by some of the degradation products when it is applied in regions with vulnerable soil and/or climatic conditions, |

No

Common name, identification numbers

IUPAC name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

‘175

Amidosulfuron

CAS No 120923-37-7

CIPAC No 515

3-(4,6-dimethoxypyrimidin-2-yl)-1-(N-methyl-N-methylsulfonyl-aminosulfonyl)urea

or

1-(4,6-dimethoxypyrimidin-2-yl)-3-mesyl(methyl) sulfamoylurea

≥ 970 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

In assessing applications to authorise plant protection products containing amidosulfuron for uses other than meadows and pasture, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on amidosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

—

the protection of groundwater due to a potential for groundwater contamination by some of the degradation products when it is applied in regions with vulnerable soil and/or climatic conditions,

| — | the protection of aquatic plants. |
| --- | --- |

—

the protection of aquatic plants.

In relation to these identified risks, risk mitigation measures, such as buffer zones, should be applied where appropriate.

176

Nicosulfuron

CAS No 111991-09-4

CIPAC No 709

2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-N,N-dimethylnicotinamide

or

1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-dimethylcarbamoyl-2-pyridylsulfonyl)urea

≥ 930 g/kg

1 January 2009

31 December 2018

PART A

Only uses as herbicide may be authorised.

PART B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on nicosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2008 shall be taken into account.

In this overall assessment Member States must pay particular attention to:

| — | the potential exposure of the aquatic environment to metabolite DUDN when nicosulfuron is applied in regions with vulnerable soil conditions, |
| --- | --- |

—

the potential exposure of the aquatic environment to metabolite DUDN when nicosulfuron is applied in regions with vulnerable soil conditions,

| — | the protection of aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones, |
| --- | --- |

—

the protection of aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as buffer zones,

| — | the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no-spray buffer zone, |
| --- | --- |

—

the protection of non-target plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures such as an in-field no-spray buffer zone,

| — | the protection of groundwater and surface water under vulnerable soil and climatic conditions.’ |
| --- | --- |

—

the protection of groundwater and surface water under vulnerable soil and climatic conditions.’

---

(1)  Further details on identity and specification of active substance are provided in the review report.

1

---

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

DECISIONS

Council

| 29.3.2008 | EN | Official Journal of the European Union | L 87/9 |
| --- | --- | --- | --- |

29.3.2008

EN

Official Journal of the European Union

L 87/9

---

COUNCIL DECISION

of 17 March 2008

on the conclusion of the Agreement between the European Community and the Kingdom of Morocco on certain aspects of air services

(2008/274/EC)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 80(2), in conjunction with the first sentence of the first subparagraph of Article 300(2), and the first subparagraph of Article 300(3),

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Parliament (1),

Whereas:

| (1) | On 5 June 2003, the Council authorised the Commission to open negotiations with third countries on the replacement of certain provisions in existing bilateral agreements with a Community Agreement. |
| --- | --- |

(1)

On 5 June 2003, the Council authorised the Commission to open negotiations with third countries on the replacement of certain provisions in existing bilateral agreements with a Community Agreement.

| (2) | The Commission has negotiated, on behalf of the Community, an Agreement with the Kingdom of Morocco on certain aspects of air services (the Agreement) in accordance with the mechanisms and directives in the Annex to the Council Decision authorising the Commission to open negotiations with third countries on the replacement of certain provisions in existing bilateral agreements with a Community Agreement. |
| --- | --- |

(2)

The Commission has negotiated, on behalf of the Community, an Agreement with the Kingdom of Morocco on certain aspects of air services (the Agreement) in accordance with the mechanisms and directives in the Annex to the Council Decision authorising the Commission to open negotiations with third countries on the replacement of certain provisions in existing bilateral agreements with a Community Agreement.

| (3) | The Agreement was signed on behalf of the European Community subject to its possible conclusion at a later date, in conformity with Council Decision 2006/953/EC (2). |
| --- | --- |

(3)

The Agreement was signed on behalf of the European Community subject to its possible conclusion at a later date, in conformity with Council Decision 2006/953/EC (2).

| (4) | The Agreement should be approved, |
| --- | --- |

(4)

The Agreement should be approved,

HAS DECIDED AS FOLLOWS:

Article 1

The Agreement between the European Community and the Kingdom of Morocco on certain aspects of air services is hereby approved on behalf of the Community.

Article 2

The President of the Council is authorised to designate the person empowered to make the notification provided for in Article 8(1) of the Agreement.

Done at Brussels, 17 March 2008.

For the Council

The President

I. JARC

---

(1)  Opinion of 16.5.2006 (not yet published in the Official Journal).

1

(2)  
  OJ L 386, 29.12.2006, p. 17.

2

---

| 29.3.2008 | EN | Official Journal of the European Union | L 87/10 |
| --- | --- | --- | --- |

29.3.2008

EN

Official Journal of the European Union

L 87/10

---

COUNCIL DECISION

of 17 March 2008

on the conclusion of a Protocol amending Annexes I and II to the Agreement between the European Community and the Kingdom of Morocco on certain aspects of air services, in order to take account of the accession to the European Union of the Republic of Bulgaria and Romania

(2008/275/EC)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community and in particular Article 80(2) thereof in conjunction with Article 300(2), the first subparagraph of Article 300(3) and Article 300(4),

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Parliament (1),

Whereas:

| (1) | Bulgaria and Romania signed bilateral Air Service Agreements with the Kingdom of Morocco on 14 October 1966 and 6 December 1971 respectively. |
| --- | --- |

(1)

Bulgaria and Romania signed bilateral Air Service Agreements with the Kingdom of Morocco on 14 October 1966 and 6 December 1971 respectively.

| (2) | The Commission has negotiated with third countries on the replacement of certain provisions appearing in the existing bilateral agreements by a Community Agreement. |
| --- | --- |

(2)

The Commission has negotiated with third countries on the replacement of certain provisions appearing in the existing bilateral agreements by a Community Agreement.

| (3) | The Agreement between the European Community and the Kingdom of Morocco on certain aspects of air services (2) (hereinafter referred to as the horizontal Agreement) was signed at Brussels on 12 December 2006 and has been applied provisionally from that date. |
| --- | --- |

(3)

The Agreement between the European Community and the Kingdom of Morocco on certain aspects of air services (2) (hereinafter referred to as the horizontal Agreement) was signed at Brussels on 12 December 2006 and has been applied provisionally from that date.

| (4) | The Treaty of Accession of the Republic of Bulgaria and Romania to the European Union (3) was signed at Luxembourg on 25 April 2005 and entered into force on 1 January 2007. |
| --- | --- |

(4)

The Treaty of Accession of the Republic of Bulgaria and Romania to the European Union (3) was signed at Luxembourg on 25 April 2005 and entered into force on 1 January 2007.

| (5) | A Protocol amending Annexes I and II to the horizontal Agreement is necessary in order to take account of the accession of the two new Member States. |
| --- | --- |

(5)

A Protocol amending Annexes I and II to the horizontal Agreement is necessary in order to take account of the accession of the two new Member States.

| (6) | The Protocol amending Annexes I and II to the Agreement between the European Community and the Kingdom of Morocco on certain aspects of air services was initialled on 19 March 2007. |
| --- | --- |

(6)

The Protocol amending Annexes I and II to the Agreement between the European Community and the Kingdom of Morocco on certain aspects of air services was initialled on 19 March 2007.

| (7) | The Protocol should be approved, |
| --- | --- |

(7)

The Protocol should be approved,

HAS DECIDED AS FOLLOWS:

Article 1

The Protocol amending Annexes I and II to the Agreement between the European Community and the Kingdom of Morocco on certain aspects of air services (hereinafter referred to as the Protocol) is hereby approved on behalf of the Community.

The text of the Protocol is attached to this Decision.

Article 2

The President of the Council shall, on behalf of the Community, give the notification provided for in Article 3 of the Protocol (4).

Done at Brussels, 17 March 2008.

For the Council

The President

I. JARC

---

(1)  Opinion of 11 December 2007 (not yet published in the Official Journal).

1

(2)  
  OJ L 386, 29.12.2006, p. 18.

2

(3)  
  OJ L 157, 21.6.2005, p. 11.

3

(4)  The date of entry into force of the Protocol will be published in the Official Journal of the European Union by the General Secretariat of the Council.

4

Official Journal of the European Union

---

PROTOCOL

amending Annexes I and II to the Agreement between the European Community and the Kingdom of Morocco on certain aspects of air services

THE EUROPEAN COMMUNITY,

of the one part, and

THE KINGDOM OF MOROCCO,

of the other part,

hereinafter referred to as ‘the Parties’,

Having regard to the Agreements between Bulgaria and Romania and the Kingdom of Morocco, signed on 14 October 1966 at Rabat and 6 December 1971 at Bucharest respectively,

Having regard to the Agreement between the European Community and the Republic of Morocco on certain aspects of air services, signed at Brussels on 12 December 2006 (hereinafter referred to as the horizontal Agreement),

Having regard to the accession of the Republic of Bulgaria and Romania to the European Union and hence to the Community on 1 January 2007,

HAVE AGREED AS FOLLOWS:

Article 1

The following provisions shall be added to Annex 1(a) of the horizontal Agreement:

| ‘— | Aviation Agreement between the People’s Republic of Bulgaria and the Kingdom of Morocco signed at Rabat on 14 October 1966 (hereinafter referred to as the Morocco-Bulgaria Agreement); |
| --- | --- |

‘—

Aviation Agreement between the People’s Republic of Bulgaria and the Kingdom of Morocco signed at Rabat on 14 October 1966 (hereinafter referred to as the Morocco-Bulgaria Agreement);

| — | Civil Aviation Agreement between the Government of the Socialist Republic of Romania and the Government of the Kingdom of Morocco signed at Bucharest on 6 December 1971 (hereinafter referred to as the Morocco-Romania Agreement), |
| --- | --- |

—

Civil Aviation Agreement between the Government of the Socialist Republic of Romania and the Government of the Kingdom of Morocco signed at Bucharest on 6 December 1971 (hereinafter referred to as the Morocco-Romania Agreement),

as amended by the Memorandum of Understanding signed at Rabat on 29 February 1996.’

Article 2

The following provisions shall be added to Annex II of the horizontal Agreement:

| | in point (a) (Designation by a Member State):






  ‘— | Article 3 of the Morocco-Romania Agreement.’; |
| --- | --- | --- |

in point (a) (Designation by a Member State):

‘—

Article 3 of the Morocco-Romania Agreement.’;

| | in point (b) (Refusal, revocation, suspension or limitation of authorisations or permissions):






  ‘— | Article 7 of the Morocco-Bulgaria Agreement; |
| --- | --- | --- |

in point (b) (Refusal, revocation, suspension or limitation of authorisations or permissions):

‘—

Article 7 of the Morocco-Bulgaria Agreement;

| — | Article 3 and 4 of the Morocco-Romania Agreement.’; |
| --- | --- |

—

Article 3 and 4 of the Morocco-Romania Agreement.’;

| | in point (c) (Regulatory control):






  ‘— | Article 8 of the Morocco-Bulgaria Agreement.’; |
| --- | --- | --- |

in point (c) (Regulatory control):

‘—

Article 8 of the Morocco-Bulgaria Agreement.’;

| | in point (d) (Taxation of aviation fuel):






  ‘— | Article 3 of the Morocco-Bulgaria Agreement; |
| --- | --- | --- |

in point (d) (Taxation of aviation fuel):

‘—

Article 3 of the Morocco-Bulgaria Agreement;

| — | Article 8 of the Morocco-Romania Agreement.’; |
| --- | --- |

—

Article 8 of the Morocco-Romania Agreement.’;

| | in point (e) (Tariffs for carriage within the European Community):






  ‘— | Article 16 of the Morocco-Bulgaria Agreement; |
| --- | --- | --- |

in point (e) (Tariffs for carriage within the European Community):

‘—

Article 16 of the Morocco-Bulgaria Agreement;

| — | Article 7 of the Morocco-Romania Agreement.’ |
| --- | --- |

—

Article 7 of the Morocco-Romania Agreement.’

Article 3

This Protocol shall enter into force on the date on which the Parties notify each other of the completion of their respective internal approval procedures to that end.

Article 4

This Protocol shall be drawn up in the Bulgarian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish and Arabic languages, each text being equally authentic.

---

Commission

| 29.3.2008 | EN | Official Journal of the European Union | L 87/12 |
| --- | --- | --- | --- |

29.3.2008

EN

Official Journal of the European Union

L 87/12

---

COMMISSION DECISION

of 17 March 2008

amending Decision 2005/338/EC in order to prolong the validity of the ecological criteria for the award of the Community eco-label to campsite service

(notified under document number C(2008) 1128)

(Text with EEA relevance)

(2008/276/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 1980/2000 of the European Parliament and of the Council of 17 July 2000 on a revised Community eco-label award scheme (1), and in particular the second subparagraph of Article 6(1) thereof,

After consulting the European Union Eco-labelling Board,

Whereas:

| (1) | The ecological criteria set out in Commission Decision 2005/338/EC of 14 April 2005 establishing the ecological criteria for the award of the Community eco-label to campsite service (2) expire on 14 April 2008. |
| --- | --- |

(1)

The ecological criteria set out in Commission Decision 2005/338/EC of 14 April 2005 establishing the ecological criteria for the award of the Community eco-label to campsite service (2) expire on 14 April 2008.

| (2) | Pursuant to Regulation (EC) No 1980/2000 a timely review has been undertaken of the ecological criteria, as well as of the related assessment and verification requirements, established by Commission Decision 2005/338/EC. |
| --- | --- |

(2)

Pursuant to Regulation (EC) No 1980/2000 a timely review has been undertaken of the ecological criteria, as well as of the related assessment and verification requirements, established by Commission Decision 2005/338/EC.

| (3) | Given the different stages of the revision process it is appropriate to prolong the relevant period of validity for a period of 18 months. |
| --- | --- |

(3)

Given the different stages of the revision process it is appropriate to prolong the relevant period of validity for a period of 18 months.

| (4) | Decision 2005/338/EC should therefore be amended accordingly. |
| --- | --- |

(4)

Decision 2005/338/EC should therefore be amended accordingly.

| (5) | The measures provided for in this Decision are in accordance with the opinion of the Committee instituted by Article 17 of Regulation (EC) No 1980/2000, |
| --- | --- |

(5)

The measures provided for in this Decision are in accordance with the opinion of the Committee instituted by Article 17 of Regulation (EC) No 1980/2000,

HAS ADOPTED THIS DECISION:

Article 1

Article 5 of Decision 2005/338/EC is replaced by the following:

‘Article 5

The ecological criteria for the product group “campsite service”, as well as the related assessment and verification requirements, shall be valid until 31 October 2009.’.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 17 March 2008.

For the Commission

Stavros DIMAS

Member of the Commission

---

(1)  
  OJ L 237, 21.9.2000, p. 1.

1

(2)  
  OJ L 108, 29.4.2005, p. 67.

2

---

| 29.3.2008 | EN | Official Journal of the European Union | L 87/14 |
| --- | --- | --- | --- |

29.3.2008

EN

Official Journal of the European Union

L 87/14

---

COMMISSION DECISION

of 26 March 2008

amending Decision 2001/405/EC in order to prolong the validity of the ecological criteria for the award of the Community eco-label to tissue paper products

(notified under document number C(2008) 1222)

(Text with EEA relevance)

(2008/277/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 1980/2000 of the European Parliament and of the Council of 17 July 2000 on a revised Community eco-label award scheme (1), and in particular the second subparagraph of Article 6(1) thereof,

After consulting the European Union Eco-labelling Board,

Whereas:

| (1) | The ecological criteria set out in the Commission Decision 2001/405/EC of 4 May 2001 establishing the ecological criteria for the award of the Community eco-label to tissue paper products (2) expires on 4 May 2008. |
| --- | --- |

(1)

The ecological criteria set out in the Commission Decision 2001/405/EC of 4 May 2001 establishing the ecological criteria for the award of the Community eco-label to tissue paper products (2) expires on 4 May 2008.

| (2) | Pursuant to Regulation (EC) No 1980/2000 a timely review has been carried out of the ecological criteria, as well as of the related assessment and verification requirements, established by this Decision. |
| --- | --- |

(2)

Pursuant to Regulation (EC) No 1980/2000 a timely review has been carried out of the ecological criteria, as well as of the related assessment and verification requirements, established by this Decision.

| (3) | In the light of the review of those criteria and requirements, it is appropriate to prolong the period of validity of the ecological criteria and the requirements for Decision 2001/405/EC for a period of 12 months. |
| --- | --- |

(3)

In the light of the review of those criteria and requirements, it is appropriate to prolong the period of validity of the ecological criteria and the requirements for Decision 2001/405/EC for a period of 12 months.

| (4) | Since the review obligation pursuant to Regulation (EC) No 1980/2000 concerns only the ecological criteria and assessment and verification requirements, it is appropriate that Decision 2001/405/EC remains in effect. |
| --- | --- |

(4)

Since the review obligation pursuant to Regulation (EC) No 1980/2000 concerns only the ecological criteria and assessment and verification requirements, it is appropriate that Decision 2001/405/EC remains in effect.

| (5) | Decision 2001/405/EC should therefore be amended accordingly. |
| --- | --- |

(5)

Decision 2001/405/EC should therefore be amended accordingly.

| (6) | The measures provided for in this Decision are in accordance with the opinion of the Committee instituted by Article 17 of Regulation (EC) No 1980/2000, |
| --- | --- |

(6)

The measures provided for in this Decision are in accordance with the opinion of the Committee instituted by Article 17 of Regulation (EC) No 1980/2000,

HAS ADOPTED THIS DECISION:

Article 1

Article 3 of Decision 2001/405/EC is replaced by the following:

‘Article 3

The ecological criteria for the product group tissue paper, as well as the related assessment and verification requirements, shall be valid until 4 May 2009.’

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 26 March 2008.

For the Commission

Stavros DIMAS

Member of the Commission

---

(1)  
  OJ L 237, 21.9.2000, p. 1.

1

(2)  
  OJ L 142, 29.5.2001, p. 10. Decision as last amended by Decision 2007/207/EC (OJ L 92, 3.4.2007, p. 16).

2

---

| 29.3.2008 | EN | Official Journal of the European Union | L 87/15 |
| --- | --- | --- | --- |

29.3.2008

EN

Official Journal of the European Union

L 87/15

---

COMMISSION DECISION

of 26 March 2008

amending Decision 2006/589/EC as regards aviglycine HCl

(notified under document number C(2008) 1071)

(Text with EEA relevance)

(2008/278/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(3) thereof,

Whereas:

| (1) | In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 27 October 2004 an application from Valent Bioscience, for the inclusion of the active substance aviglycine HCl in Annex I to Directive 91/414/EEC. |
| --- | --- |

(1)

In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 27 October 2004 an application from Valent Bioscience, for the inclusion of the active substance aviglycine HCl in Annex I to Directive 91/414/EEC.

| (2) | By Commission Decision 2006/589/EC (2) it was confirmed that, on preliminary examination, the dossier was ‘complete’, in that it could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to Directive 91/414/EEC. |
| --- | --- |

(2)

By Commission Decision 2006/589/EC (2) it was confirmed that, on preliminary examination, the dossier was ‘complete’, in that it could be considered as satisfying, in principle, the data and information requirements of Annex II and Annex III to Directive 91/414/EEC.

| (3) | Member States were thereby given the possibility to grant provisional authorisations for plant protection products containing aviglycine HCl, in accordance with Article 8(1) of Directive 91/414/EEC. No Member State has used this possibility. |
| --- | --- |

(3)

Member States were thereby given the possibility to grant provisional authorisations for plant protection products containing aviglycine HCl, in accordance with Article 8(1) of Directive 91/414/EEC. No Member State has used this possibility.

| (4) | The United Kingdom, as rapporteur Member State, has indicated to the Commission that a detailed examination of the dossier revealed that several additional items of data were still required under Annexes II and III of Directive 91/414/EEC. Accordingly, the dossier can no longer be considered to be complete. |
| --- | --- |

(4)

The United Kingdom, as rapporteur Member State, has indicated to the Commission that a detailed examination of the dossier revealed that several additional items of data were still required under Annexes II and III of Directive 91/414/EEC. Accordingly, the dossier can no longer be considered to be complete.

| (5) | The notifier for aviglycine HCl informed the United Kingdom and the Commission of its intention not to support the ongoing evaluation any further and not to submit further data. As a result, it is clear that the dossier will be not completed and that it will thus be impossible for the rapporteur Member State to draft an assessment report concerning aviglycine HCl and distribute it to the Commission, the European Food Safety Authority and the other Member States. The possibility of granting provisional authorisations should therefore be withdrawn. |
| --- | --- |

(5)

The notifier for aviglycine HCl informed the United Kingdom and the Commission of its intention not to support the ongoing evaluation any further and not to submit further data. As a result, it is clear that the dossier will be not completed and that it will thus be impossible for the rapporteur Member State to draft an assessment report concerning aviglycine HCl and distribute it to the Commission, the European Food Safety Authority and the other Member States. The possibility of granting provisional authorisations should therefore be withdrawn.

| (6) | No period of grace for disposal, storage, placing in the market and use of existing stocks of plant protection products containing aviglycine HCl is necessary as no Member State has granted a provisional authorisation for this active substance. |
| --- | --- |

(6)

No period of grace for disposal, storage, placing in the market and use of existing stocks of plant protection products containing aviglycine HCl is necessary as no Member State has granted a provisional authorisation for this active substance.

| (7) | Decision 2006/589/EC should therefore be amended accordingly. |
| --- | --- |

(7)

Decision 2006/589/EC should therefore be amended accordingly.

| (8) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(8)

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 Annex to Decision 2006/589/EC is replaced by the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Done in Brussels, 26 March 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission

---

(1)  
  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/76/EC (OJ L 337, 21.12.2007, p. 100).

1

(2)  
  OJ L 240, 2.9.2006, p. 9.

2

---

ANNEX

ACTIVE SUBSTANCES CONCERNED BY THIS DECISION

| No | Common Name, CIPAC Identification Number | Applicant | Date of application | Rapporteur Member State |
| --- | --- | --- | --- | --- |
| 1 | Mandipropamid
  CIPAC-No: not yet allocated | Syngenta AG | 13.12.2005 | AT |
| 2 | Meptyldinocap
  CIPAC-No: not yet allocated | Dow AgroSciences | 12.8.2005 | UK |

No

Common Name, CIPAC Identification Number

Applicant

Date of application

Rapporteur Member State

1

Mandipropamid

CIPAC-No: not yet allocated

Syngenta AG

13.12.2005

AT

2

Meptyldinocap

CIPAC-No: not yet allocated

Dow AgroSciences

12.8.2005

UK

---

| 29.3.2008 | EN | Official Journal of the European Union | L 87/17 |
| --- | --- | --- | --- |

29.3.2008

EN

Official Journal of the European Union

L 87/17

---

COMMISSION DECISION

of 28 March 2008

repealing Decision 2006/69/EC authorising the placing on the market of foods and food ingredients produced from genetically modified Roundup Ready maize line GA21 as novel foods or novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document number C(2008) 1116)

(Only the French and Dutch texts are authentic)

(2008/279/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1),

Whereas:

| (1) | Foods and food ingredients produced from genetically modified maize line GA21 (MON-ØØØ21-9) have been authorised for placing on the market as novel food or novel food ingredients by Commission Decision 2006/69/EC of 13 January 2006 authorising the placing on the market of food and food ingredients produced from genetically modified Roundup Ready maize line GA21 as novel foods and novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council (2). |
| --- | --- |

(1)

Foods and food ingredients produced from genetically modified maize line GA21 (MON-ØØØ21-9) have been authorised for placing on the market as novel food or novel food ingredients by Commission Decision 2006/69/EC of 13 January 2006 authorising the placing on the market of food and food ingredients produced from genetically modified Roundup Ready maize line GA21 as novel foods and novel food ingredients under Regulation (EC) No 258/97 of the European Parliament and of the Council (2).

| (2) | That Decision was addressed to Monsanto Europe S.A., Belgium, representing Monsanto Company, USA, and was valid for 10 years. |
| --- | --- |

(2)

That Decision was addressed to Monsanto Europe S.A., Belgium, representing Monsanto Company, USA, and was valid for 10 years.

| (3) | By letter of 1 March 2007 to the Commission, Monsanto Europe S.A., taking into consideration that Syngenta Seeds S.A.S. has submitted an application for the placing on the market of GA21 maize products, indicated that it had discontinued GA21 seed production several years ago and seed sales in 2005, and thus it had no interest to maintain this authorisation as of the entry into force of the authorisation granted to Syngenta. |
| --- | --- |

(3)

By letter of 1 March 2007 to the Commission, Monsanto Europe S.A., taking into consideration that Syngenta Seeds S.A.S. has submitted an application for the placing on the market of GA21 maize products, indicated that it had discontinued GA21 seed production several years ago and seed sales in 2005, and thus it had no interest to maintain this authorisation as of the entry into force of the authorisation granted to Syngenta.

| (4) | On 2 October 2007, the European Food Safety Authority gave a favourable opinion for an application submitted by Syngenta, under Regulation (EC) No 1829/2003 and including products covered by Decision 2006/69/EC. |
| --- | --- |

(4)

On 2 October 2007, the European Food Safety Authority gave a favourable opinion for an application submitted by Syngenta, under Regulation (EC) No 1829/2003 and including products covered by Decision 2006/69/EC.

| (5) | As a consequence, it is appropriate to provide that the repeal of Decision 2006/69/EC should apply from the day of application of the authorisation granted to Syngenta for GA21 products. |
| --- | --- |

(5)

As a consequence, it is appropriate to provide that the repeal of Decision 2006/69/EC should apply from the day of application of the authorisation granted to Syngenta for GA21 products.

| (6) | The entries in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003, regarding MON-ØØØ21-9 maize should be modified in order to take account of this Decision. |
| --- | --- |

(6)

The entries in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003, regarding MON-ØØØ21-9 maize should be modified in order to take account of this Decision.

| (7) | Monsanto Europe S.A. has been consulted on the measures provided for in this Decision. |
| --- | --- |

(7)

Monsanto Europe S.A. has been consulted on the measures provided for in this Decision.

| (8) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(8)

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

Decision 2006/69/EC is repealed.

Article 2

The entries in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003, regarding MON-ØØØ21-9 maize shall be modified in order to take account of this Decision.

Article 3

This Decision shall apply from the date a Community Decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 and addressed to Syngenta Seeds S.A.S. is published in the Official Journal of the European Union.

Article 4

This Decision is addressed to Monsanto Europe S.A., Scheldelaan 460, Haven 627, B-2040 Antwerpen, Belgium.

Done in Brussels, 28 March 2008.

For the Commission

Androulla VASSILIOU

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 34, 7.2.2006, p. 29.

2

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| 29.3.2008 | EN | Official Journal of the European Union | L 87/19 |
| --- | --- | --- | --- |

29.3.2008

EN

Official Journal of the European Union

L 87/19

---

COMMISSION DECISION

of 28 March 2008

authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document number C(2008) 1112)

(Only the French text is authentic)

(2008/280/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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

Whereas:

| (1) | On 29 July 2005, Syngenta Seeds S.A.S., on behalf of Syngenta Crop Protection AG, submitted to the competent authorities of the United Kingdom an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from GA21 maize. |
| --- | --- |

(1)

On 29 July 2005, Syngenta Seeds S.A.S., on behalf of Syngenta Crop Protection AG, submitted to the competent authorities of the United Kingdom an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from GA21 maize.

| (2) | That application also covers the placing on the market of other products containing or consisting of GA21 maize for the same uses as any other maize with the exception of cultivation. Therefore, in accordance with the provision of Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, it includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. |
| --- | --- |

(2)

That application also covers the placing on the market of other products containing or consisting of GA21 maize for the same uses as any other maize with the exception of cultivation. Therefore, in accordance with the provision of Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, it includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC.

| (3) | On 17 April 2007, Syngenta Seeds S.A.S., on behalf of Syngenta Crop Protection AG, submitted to the Commission an application, in accordance with Articles 8(4) and 20(4) of Regulation (EC) No 1829/2003, for the authorisation of existing products produced from GA21 maize (food additives, feed materials and feed additives produced from GA21 maize). |
| --- | --- |

(3)

On 17 April 2007, Syngenta Seeds S.A.S., on behalf of Syngenta Crop Protection AG, submitted to the Commission an application, in accordance with Articles 8(4) and 20(4) of Regulation (EC) No 1829/2003, for the authorisation of existing products produced from GA21 maize (food additives, feed materials and feed additives produced from GA21 maize).

| (4) | On 2 October 2007, the European Food Safety Authority (EFSA) gave a single comprehensive favourable opinion for both applications in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 and concluded that it is unlikely that the placing on the market of the products containing, consisting of, or produced from GA21 maize as described in the applications (the products) will have adverse effects on human or animal health or the environment (3). In its opinion, EFSA considered all specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities provided for by Articles 6(4) and 18(4) of that Regulation. |
| --- | --- |

(4)

On 2 October 2007, the European Food Safety Authority (EFSA) gave a single comprehensive favourable opinion for both applications in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 and concluded that it is unlikely that the placing on the market of the products containing, consisting of, or produced from GA21 maize as described in the applications (the products) will have adverse effects on human or animal health or the environment (3). In its opinion, EFSA considered all specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities provided for by Articles 6(4) and 18(4) of that Regulation.

| (5) | In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended use of the products. |
| --- | --- |

(5)

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

| (6) | Taking into account those considerations, authorisation should be granted for the products. |
| --- | --- |

(6)

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

| (7) | A unique identifier should be assigned to each GMO as provided for in Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (4). |
| --- | --- |

(7)

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

| (8) | On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 appear to be necessary for the foods, food ingredients, and feed containing, consisting of, or produced from GA21 maize. However, in order to ensure the use of the products within the limits of authorisation provided by this Decision, the labelling of feed containing or consisting of the GMO and other products than food and feed containing or consisting of the GMO for which authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation. |
| --- | --- |

(8)

On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 appear to be necessary for the foods, food ingredients, and feed containing, consisting of, or produced from GA21 maize. However, in order to ensure the use of the products within the limits of authorisation provided by this Decision, the labelling of feed containing or consisting of the GMO and other products than food and feed containing or consisting of the GMO for which authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation.

| (9) | Similarly, the EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Articles 6(5) and 18(5) of Regulation (EC) No 1829/2003. |
| --- | --- |

(9)

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

| (10) | All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed as provided for in Regulation (EC) No 1829/2003. |
| --- | --- |

(10)

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

| (11) | Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending directive 2001/18/EC (5), lays down labelling requirements for products consisting of or containing GMOs. |
| --- | --- |

(11)

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

| (12) | This Decision is to be notified through the Biosafety Clearing House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2)(c), of Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (6). |
| --- | --- |

(12)

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

| (13) | The Standing Committee on the Food Chain and Animal Health did not deliver an opinion within the time limit laid down by its Chairman. The Commission therefore submitted to the Council a proposal relating to these measures. |
| --- | --- |

(13)

The Standing Committee on the Food Chain and Animal Health did not deliver an opinion within the time limit laid down by its Chairman. The Commission therefore submitted to the Council a proposal relating to these measures.

| (14) | At its meeting on 18 February 2008, the Council was unable to reach a decision by qualified majority either for or against the proposal. The Council indicated that its proceedings on this file were concluded and that the Commission could finalise the decision-making process. It is accordingly for the Commission to adopt the measures, |
| --- | --- |

(14)

At its meeting on 18 February 2008, the Council was unable to reach a decision by qualified majority either for or against the proposal. The Council indicated that its proceedings on this file were concluded and that the Commission could finalise the decision-making process. It is accordingly for the Commission to adopt the measures,

HAS ADOPTED THIS DECISION:

Article 1

Genetically modified organism and unique identifier

Genetically modified maize (Zea mays L.) GA21, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-ØØØ21-9, as provided for in Regulation (EC) No 65/2004.

Zea mays

Article 2

Authorisation

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

| (a) | foods and food ingredients containing, consisting of, or produced from MON-ØØØ21-9 maize; |
| --- | --- |

(a)

foods and food ingredients containing, consisting of, or produced from MON-ØØØ21-9 maize;

| (b) | feed containing, consisting of, or produced from MON-ØØØ21-9 maize; |
| --- | --- |

(b)

feed containing, consisting of, or produced from MON-ØØØ21-9 maize;

| (c) | products, other than food and feed, containing or consisting of MON-ØØØ21-9 maize for the same uses as any other maize with the exception of cultivation. |
| --- | --- |

(c)

products, other than food and feed, containing or consisting of MON-ØØØ21-9 maize for the same uses as any other maize with the exception of cultivation.

Article 3

Labelling

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

2.   The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of MON-ØØØ21-9 maize referred to in Article 2(b) and (c).

Article 4

Monitoring for environmental effects

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

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

Article 5

Community register

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

Article 6

Authorisation holder

The authorisation holder shall be Syngenta Seeds S.A.S., France, representing Syngenta Crop Protection AG, Switzerland.

Article 7

Validity

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

Article 8

Addressee

This Decision is addressed to Syngenta Seeds S.A.S., Chemin de l’Hobit 12, BP 27, F-31790 Saint-Sauveur, France.

Done in Brussels, 28 March 2008.

For the Commission

Androulla VASSILIOU

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 106, 17.4.2001, p. 1. Directive as last amended by Regulation (EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).

2

(3)  http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753816_1178620785956.htm

3

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

4

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

5

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

6

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ANNEX

(a)   Applicant and Authorisation holder:

| Name | : | Syngenta Seeds S.A.S. |
| --- | --- | --- |
| Address | : | Chemin de l’Hobit 12, BP 27, F-31790 Saint-Sauveur, France |

Name

:

Syngenta Seeds S.A.S.

Address

:

Chemin de l’Hobit 12, BP 27, F-31790 Saint-Sauveur, France

On behalf of Syngenta Crop Protection AG, Schwarzwaldallee 215, CH 4058 Basle, Switzerland

(b)   Designation and specification of the products:

| (1) | Foods and food ingredients containing, consisting of, or produced from MON-ØØØ21-9 maize; |
| --- | --- |

(1)

Foods and food ingredients containing, consisting of, or produced from MON-ØØØ21-9 maize;

| (2) | Feed containing, consisting of, or produced from MON-ØØØ21-9 maize; |
| --- | --- |

(2)

Feed containing, consisting of, or produced from MON-ØØØ21-9 maize;

| (3) | Products other than food and feed containing or consisting of MON-ØØØ21-9 maize for the same uses as any other maize with the exception of cultivation. |
| --- | --- |

(3)

Products other than food and feed containing or consisting of MON-ØØØ21-9 maize for the same uses as any other maize with the exception of cultivation.

The genetically modified maize MON-ØØØ21-9, as described in the application, expresses the mEPSPS protein which confers tolerance to herbicide glyphosate

(c)   Labelling:

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

(1)

| (2) | The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of MON-ØØØ21-9 maize referred to in Article 2(b) and (c). |
| --- | --- |

(2)

(d)   Method for detection:

| — | Event specific real-time quantitative PCR based methods for genetically modified maize MON-ØØØ21-9, |
| --- | --- |

—

Event specific real-time quantitative PCR based methods for genetically modified maize MON-ØØØ21-9,

| — | Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.it/statusofdoss.htm |
| --- | --- |

—

Validated by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.it/statusofdoss.htm

| — | Reference Material: AOCS 0407-A and AOCS 0407-B accessible via the American Oil Chemists Society (AOCS) at http://www.aocs.org |
| --- | --- |

—

Reference Material: AOCS 0407-A and AOCS 0407-B accessible via the American Oil Chemists Society (AOCS) at http://www.aocs.org

(e)   Unique identifier:

MON-ØØØ21-9

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

Biosafety Clearing House, Record ID: see [to be completed when notified]

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

Not required.

(h)   Monitoring plan

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

[Link: plan published on the Internet]

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

Not required.

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

---