# Official Journal L 224/2010

| | ISSN 1725-2555
  doi:10.3000/17252555.L_2010.224.eng |
| --- | --- |
| Official Journal
  of the European Union | L 224 |
| | |
| English edition | Legislation | Volume 5326 August 2010 |

ISSN 1725-2555

doi:10.3000/17252555.L_2010.224.eng

Official Journal

of the European Union

L 224

English edition

Legislation

Volume 5326 August 2010

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Regulation (EU) No 761/2010 of 25 August 2010 amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance methylprednisolone (
  1
  ) | 1 |
| | | Commission Regulation (EU) No 762/2010 of 25 August 2010 establishing the standard import values for determining the entry price of certain fruit and vegetables | 4 |
| | | DECISIONS |
| | | 2010/466/EU |
| | * | Commission Decision of 24 August 2010 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of penthiopyrad in Annex I to Council Directive 91/414/EEC
  (notified under document C(2010) 5556)

   (
  1
  ) | 6 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Regulation (EU) No 761/2010 of 25 August 2010 amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance methylprednisolone (
  1
  )

1

1

Commission Regulation (EU) No 762/2010 of 25 August 2010 establishing the standard import values for determining the entry price of certain fruit and vegetables

4

DECISIONS

2010/466/EU

*

Commission Decision of 24 August 2010 recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of penthiopyrad in Annex I to Council Directive 91/414/EEC
  (notified under document C(2010) 5556)

   (
  1
  )

(notified under document C(2010) 5556)

1

6

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

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(1)   Text with EEA relevance

1

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

EN

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

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

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II Non-legislative acts

REGULATIONS

| 26.8.2010 | EN | Official Journal of the European Union | L 224/1 |
| --- | --- | --- | --- |

26.8.2010

EN

Official Journal of the European Union

L 224/1

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COMMISSION REGULATION (EU) No 761/2010

of 25 August 2010

amending the Annex to Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin, as regards the substance methylprednisolone

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (1), and in particular Article 14 in conjunction with Article 17 thereof,

Having regard to the opinion of the European Medicines Agency formulated by the Committee for Medicinal Products for Veterinary Use,

Whereas:

| (1) | The maximum residue limit for pharmacologically active substances intended for use in the European Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry should be established in accordance with Regulation (EC) No 470/2009. |
| --- | --- |

(1)

The maximum residue limit for pharmacologically active substances intended for use in the European Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry should be established in accordance with Regulation (EC) No 470/2009.

| (2) | Pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin are set out in the Annex to Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (2). |
| --- | --- |

(2)

Pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin are set out in the Annex to Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (2).

| (3) | Methylprednisolone is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for bovine species, applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption. |
| --- | --- |

(3)

Methylprednisolone is currently included in Table 1 of the Annex to Regulation (EU) No 37/2010 as an allowed substance, for bovine species, applicable to muscle, fat, liver and kidney, excluding animals producing milk for human consumption.

| (4) | An application for the extension of the existing entry for methylprednisolone applicable to bovine milk has been submitted to the European Medicines Agency. |
| --- | --- |

(4)

An application for the extension of the existing entry for methylprednisolone applicable to bovine milk has been submitted to the European Medicines Agency.

| (5) | The Committee for Medicinal Products for Veterinary Use has recommended to establish a provisional maximum residue limit (hereinafter ‘MRL’) for methylprednisolone for bovine milk and to remove the provision ‘not for use in animals from which milk is produced for human consumption’. |
| --- | --- |

(5)

The Committee for Medicinal Products for Veterinary Use has recommended to establish a provisional maximum residue limit (hereinafter ‘MRL’) for methylprednisolone for bovine milk and to remove the provision ‘not for use in animals from which milk is produced for human consumption’.

| (6) | The entry for methylprednisolone in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the provisional MRL for bovine milk and to remove the existing provision ‘not for use in animals from which milk is produced for human consumption’. The provisional MRL set out in that Table for methylprednisolone should expire on 1 July 2011. |
| --- | --- |

(6)

The entry for methylprednisolone in Table 1 of the Annex to Regulation (EU) No 37/2010 should therefore be amended to include the provisional MRL for bovine milk and to remove the existing provision ‘not for use in animals from which milk is produced for human consumption’. The provisional MRL set out in that Table for methylprednisolone should expire on 1 July 2011.

| (7) | It is appropriate to provide for a reasonable period of time for the stakeholders concerned to take measures that may be required to comply with the newly set MRL. |
| --- | --- |

(7)

It is appropriate to provide for a reasonable period of time for the stakeholders concerned to take measures that may be required to comply with the newly set MRL.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products, |
| --- | --- |

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Regulation (EU) No 37/2010 is amended as set out 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.

It shall apply from 25 October 2010.

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

Done at Brussels, 25 August 2010.

For the Commission

The President

José Manuel BARROSO

---

(1)  
  OJ L 152, 16.6.2009, p. 11.

1

(2)  
  OJ L 15, 20.1.2010, p. 1.

2

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ANNEX

The entry Methylprednisolone in Table 1 of the Annex to Regulation (EU) No 37/2010 shall be replaced by the following:

| Pharmacologically active substance | Marker residue | Animal species | MRL | Target tissues | Other Provisions
  (according to Article 14(7) of Regulation (EC) No 470/2009) | Therapeutic classification |
| --- | --- | --- | --- | --- | --- | --- |
| ‘Methylprednisolone | Methylprednisolone | Bovine | 10  μg/kg | Muscle | | Corticoides/Glucocorticoides’ |
| 10  μg/kg | Fat | |
| 10  μg/kg | Liver | |
| 10  μg/kg | Kidney | |
| 2  μg/kg | Milk | Provisional MRL shall expire on 1 July 2011. |

Pharmacologically active substance

Marker residue

Animal species

MRL

Target tissues

Other Provisions

(according to Article 14(7) of Regulation (EC) No 470/2009)

Therapeutic classification

‘Methylprednisolone

Methylprednisolone

Bovine

10  μg/kg

Muscle

Corticoides/Glucocorticoides’

10  μg/kg

Fat

10  μg/kg

Liver

10  μg/kg

Kidney

2  μg/kg

Milk

Provisional MRL shall expire on 1 July 2011.

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| 26.8.2010 | EN | Official Journal of the European Union | L 224/4 |
| --- | --- | --- | --- |

26.8.2010

EN

Official Journal of the European Union

L 224/4

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COMMISSION REGULATION (EU) No 762/2010

of 25 August 2010

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

THE EUROPEAN COMMISSION,

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

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

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

Whereas:

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

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

This Regulation shall enter into force on 26 August 2010.

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

Done at Brussels, 25 August 2010.

For the Commission, On behalf of the President,

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

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

1

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

2

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ANNEX

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

| (EUR/100 kg) |
| --- |
| CN code | Third country code (1) | Standard import value |
| 0702 00 00 | TR | 103,0 |
| ZZ | 103,0 |
| 0707 00 05 | TR | 137,2 |
| ZZ | 137,2 |
| 0709 90 70 | TR | 122,2 |
| ZZ | 122,2 |
| 0805 50 10 | AR | 137,7 |
| CL | 137,9 |
| TR | 153,6 |
| UY | 116,4 |
| ZA | 143,8 |
| ZZ | 137,9 |
| 0806 10 10 | BA | 91,2 |
| EG | 153,8 |
| TR | 109,6 |
| ZZ | 118,2 |
| 0808 10 80 | AR | 84,3 |
| BR | 66,4 |
| CL | 90,4 |
| CN | 65,6 |
| NZ | 92,2 |
| US | 119,8 |
| UY | 95,9 |
| ZA | 92,6 |
| ZZ | 88,4 |
| 0808 20 50 | AR | 115,4 |
| CL | 150,5 |
| CN | 80,6 |
| TR | 133,1 |
| ZA | 104,9 |
| ZZ | 116,9 |
| 0809 30 | TR | 137,0 |
| ZZ | 137,0 |
| 0809 40 05 | BA | 60,0 |
| IL | 60,2 |
| XS | 59,7 |
| ZA | 191,2 |
| ZZ | 92,8 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

TR

103,0

ZZ

103,0

0707 00 05

TR

137,2

ZZ

137,2

0709 90 70

TR

122,2

ZZ

122,2

0805 50 10

AR

137,7

CL

137,9

TR

153,6

UY

116,4

ZA

143,8

ZZ

137,9

0806 10 10

BA

91,2

EG

153,8

TR

109,6

ZZ

118,2

0808 10 80

AR

84,3

BR

66,4

CL

90,4

CN

65,6

NZ

92,2

US

119,8

UY

95,9

ZA

92,6

ZZ

88,4

0808 20 50

AR

115,4

CL

150,5

CN

80,6

TR

133,1

ZA

104,9

ZZ

116,9

0809 30

TR

137,0

ZZ

137,0

0809 40 05

BA

60,0

IL

60,2

XS

59,7

ZA

191,2

ZZ

92,8

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

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DECISIONS

| 26.8.2010 | EN | Official Journal of the European Union | L 224/6 |
| --- | --- | --- | --- |

26.8.2010

EN

Official Journal of the European Union

L 224/6

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COMMISSION DECISION

of 24 August 2010

recognising in principle the completeness of the dossier submitted for detailed examination in view of the possible inclusion of penthiopyrad in Annex I to Council Directive 91/414/EEC

(notified under document C(2010) 5556)

(Text with EEA relevance)

(2010/466/EU)

THE EUROPEAN COMMISSION,

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

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) | Directive 91/414/EEC provides for the development of a European Union list of active substances authorised for incorporation in plant protection products. |
| --- | --- |

(1)

Directive 91/414/EEC provides for the development of a European Union list of active substances authorised for incorporation in plant protection products.

| (2) | The dossier for the active substance penthiopyrad was submitted by LKC Ltd to the authorities of the United Kingdom on 10 December 2009 with the application to obtain its inclusion in Annex I to Directive 91/414/EEC. |
| --- | --- |

(2)

The dossier for the active substance penthiopyrad was submitted by LKC Ltd to the authorities of the United Kingdom on 10 December 2009 with the application to obtain its inclusion in Annex I to Directive 91/414/EEC.

| (3) | The authorities of the United Kingdom have indicated to the Commission that, on preliminary examination, the dossier for the active substance concerned appears to satisfy the data and information requirements set out in Annex II to Directive 91/414/EEC. The dossier submitted appears also to satisfy the data and information requirements set out in Annex III to Directive 91/414/EEC in respect of one plant protection product containing the active substance concerned. In accordance with Article 6(2) of Directive 91/414/EEC, the dossier was subsequently forwarded by the applicant to the Commission and other Member States, and was referred to the Standing Committee on the Food Chain and Animal Health. |
| --- | --- |

(3)

The authorities of the United Kingdom have indicated to the Commission that, on preliminary examination, the dossier for the active substance concerned appears to satisfy the data and information requirements set out in Annex II to Directive 91/414/EEC. The dossier submitted appears also to satisfy the data and information requirements set out in Annex III to Directive 91/414/EEC in respect of one plant protection product containing the active substance concerned. In accordance with Article 6(2) of Directive 91/414/EEC, the dossier was subsequently forwarded by the applicant to the Commission and other Member States, and was referred to the Standing Committee on the Food Chain and Animal Health.

| (4) | By this Decision it should be formally confirmed at European Union level that the dossier is considered as satisfying in principle the data and information requirements set out in Annex II and, for at least one plant protection product containing the active substance concerned, the requirements set out in Annex III to Directive 91/414/EEC. |
| --- | --- |

(4)

By this Decision it should be formally confirmed at European Union level that the dossier is considered as satisfying in principle the data and information requirements set out in Annex II and, for at least one plant protection product containing the active substance concerned, the requirements set out in Annex III to Directive 91/414/EEC.

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

(5)

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 dossier concerning the active substance identified in the Annex to this Decision, which was submitted to the Commission and the Member States with a view to obtaining the inclusion of that substance in Annex I to Directive 91/414/EEC, satisfies in principle the data and information requirements set out in Annex II to that Directive.

The dossier also satisfies the data and information requirements set out in Annex III to Directive 91/414/EEC in respect of one plant protection product containing the active substance, taking into account the uses proposed.

Article 2

The rapporteur Member State shall pursue the detailed examination for the dossier referred to in Article 1 and shall communicate to the Commission the conclusions of its examination accompanied by any recommendations on the inclusion or non-inclusion in Annex I to Directive 91/414/EEC of the active substance referred to in Article 1 and any conditions for that inclusion as soon as possible and by 31 August 2011 at the latest.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 24 August 2010.

For the Commission

John DALLI

Member of the Commission

---

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

1

---

ANNEX

ACTIVE SUBSTANCE CONCERNED BY THIS DECISION

| Common name, CIPAC identification number | Applicant | Date of application | Rapporteur Member State |
| --- | --- | --- | --- |
| Penthiopyrad
  CIPAC No 824 | LKC Ltd | 10.12.2009 | UK |

Common name, CIPAC identification number

Applicant

Date of application

Rapporteur Member State

Penthiopyrad

CIPAC No 824

LKC Ltd

10.12.2009

UK

---