# Official Journal L 194/2009

| | ISSN 1725-2555
  doi:10.3000/17252555.L_2009.194.eng |
| --- | --- |
| Official Journal
  of the European Union | L 194 |
| | |
| English edition | Legislation | Volume 5225 July 2009 |

ISSN 1725-2555

doi:10.3000/17252555.L_2009.194.eng

Official Journal

of the European Union

L 194

English edition

Legislation

Volume 5225 July 2009

---

| Contents | | I   Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | | Commission Regulation (EC) No 665/2009 of 24 July 2009 establishing the standard import values for determining the entry price of certain fruit and vegetables | 1 |
| | | Commission Regulation (EC) No 666/2009 of 24 July 2009 amending the representative prices and additional import duties for certain products in the sugar sector fixed by Regulation (EC) No 945/2008 for the 2008/2009 marketing year | 3 |
| | * | Commission Regulation (EC) No 667/2009 of 22 July 2009 entering a name in the register of protected designations of origin and protected geographical indications (Nocciola Romana (PDO)) | 5 |
| | * | Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises (
  1
  ) | 7 |
| | * | Commission Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC (
  1
  ) | 11 |
| | * | Commission Regulation (EC) No 670/2009 of 24 July 2009 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 as regards public intervention by invitation to tender for the purchase of durum wheat or paddy rice, and amending Regulations (EC) No 428/2008 and (EC) No 687/2008 | 22 |
| | * | Commission Regulation (EC) No 671/2009 of 24 July 2009 opening the procedure for the allocation of export licences for cheese to be exported to the United States of America in 2010 under certain GATT quotas | 47 |
| | | Commission Regulation (EC) No 672/2009 of 24 July 2009 on the issue of licences for importing rice under the tariff quotas opened for the July 2009 subperiod by Regulation (EC) No 327/98 | 53 |

Contents

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

page

REGULATIONS

Commission Regulation (EC) No 665/2009 of 24 July 2009 establishing the standard import values for determining the entry price of certain fruit and vegetables

1

Commission Regulation (EC) No 666/2009 of 24 July 2009 amending the representative prices and additional import duties for certain products in the sugar sector fixed by Regulation (EC) No 945/2008 for the 2008/2009 marketing year

3

*

Commission Regulation (EC) No 667/2009 of 22 July 2009 entering a name in the register of protected designations of origin and protected geographical indications (Nocciola Romana (PDO))

5

*

Commission Regulation (EC) No 668/2009 of 24 July 2009 implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises (
  1
  )

1

7

*

Commission Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC (
  1
  )

1

11

*

Commission Regulation (EC) No 670/2009 of 24 July 2009 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 as regards public intervention by invitation to tender for the purchase of durum wheat or paddy rice, and amending Regulations (EC) No 428/2008 and (EC) No 687/2008

22

*

Commission Regulation (EC) No 671/2009 of 24 July 2009 opening the procedure for the allocation of export licences for cheese to be exported to the United States of America in 2010 under certain GATT quotas

47

Commission Regulation (EC) No 672/2009 of 24 July 2009 on the issue of licences for importing rice under the tariff quotas opened for the July 2009 subperiod by Regulation (EC) No 327/98

53

| | | II   Acts adopted under the EC Treaty/Euratom Treaty whose publication is not obligatory |
| --- | --- | --- |
| | | DECISIONS |
| | | Commission |
| | | 2009/560/EC |
| | * | Commission Decision of 22 July 2009 approving certain amended programmes for the eradication and monitoring of animal diseases and zoonoses for the year 2009 and amending Decision 2008/897/EC as regards the Community’s financial contribution to certain Member States for programmes approved by that Decision
  (notified under document number C(2009) 5475) | 56 |
| | | 2009/561/EC |
| | * | Commission Decision of 22 July 2009 amending Decision 2006/679/EC as regards the implementation of the technical specification for interoperability relating to the control-command and signalling subsystem of the trans-European conventional rail system
  (notified under document number C(2009) 5607)

   (
  1
  ) | 60 |

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

DECISIONS

Commission

2009/560/EC

*

Commission Decision of 22 July 2009 approving certain amended programmes for the eradication and monitoring of animal diseases and zoonoses for the year 2009 and amending Decision 2008/897/EC as regards the Community’s financial contribution to certain Member States for programmes approved by that Decision
  (notified under document number C(2009) 5475)

(notified under document number C(2009) 5475)

56

2009/561/EC

*

Commission Decision of 22 July 2009 amending Decision 2006/679/EC as regards the implementation of the technical specification for interoperability relating to the control-command and signalling subsystem of the trans-European conventional rail system
  (notified under document number C(2009) 5607)

   (
  1
  )

(notified under document number C(2009) 5607)

1

60

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

| 25.7.2009 | EN | Official Journal of the European Union | L 194/1 |
| --- | --- | --- | --- |

25.7.2009

EN

Official Journal of the European Union

L 194/1

---

COMMISSION REGULATION (EC) No 665/2009

of 24 July 2009

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

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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

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

Whereas:

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

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

This Regulation shall enter into force on 25 July 2009.

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

Done at Brussels, 24 July 2009.

For the Commission

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

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

1

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

2

---

ANNEX

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

| (EUR/100 kg) |
| --- |
| CN code | Third country code (1) | Standard import value |
| 0702 00 00 | MK | 23,3 |
| ZZ | 23,3 |
| 0707 00 05 | TR | 98,9 |
| ZZ | 98,9 |
| 0709 90 70 | TR | 97,5 |
| ZZ | 97,5 |
| 0805 50 10 | AR | 49,5 |
| UY | 48,0 |
| ZA | 61,6 |
| ZZ | 53,0 |
| 0806 10 10 | EG | 151,8 |
| MA | 152,8 |
| TR | 115,0 |
| US | 141,6 |
| ZA | 127,3 |
| ZZ | 137,7 |
| 0808 10 80 | AR | 84,8 |
| BR | 69,0 |
| CL | 89,1 |
| CN | 103,8 |
| NZ | 85,6 |
| US | 91,3 |
| ZA | 86,4 |
| ZZ | 87,1 |
| 0808 20 50 | AR | 95,7 |
| CL | 81,2 |
| ZA | 104,2 |
| ZZ | 93,7 |
| 0809 10 00 | TR | 159,1 |
| ZZ | 159,1 |
| 0809 20 95 | CA | 324,1 |
| TR | 287,2 |
| US | 393,4 |
| ZZ | 334,9 |
| 0809 30 | TR | 157,2 |
| ZZ | 157,2 |
| 0809 40 05 | IL | 167,2 |
| ZZ | 167,2 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

MK

23,3

ZZ

23,3

0707 00 05

TR

98,9

ZZ

98,9

0709 90 70

TR

97,5

ZZ

97,5

0805 50 10

AR

49,5

UY

48,0

ZA

61,6

ZZ

53,0

0806 10 10

EG

151,8

MA

152,8

TR

115,0

US

141,6

ZA

127,3

ZZ

137,7

0808 10 80

AR

84,8

BR

69,0

CL

89,1

CN

103,8

NZ

85,6

US

91,3

ZA

86,4

ZZ

87,1

0808 20 50

AR

95,7

CL

81,2

ZA

104,2

ZZ

93,7

0809 10 00

TR

159,1

ZZ

159,1

0809 20 95

CA

324,1

TR

287,2

US

393,4

ZZ

334,9

0809 30

TR

157,2

ZZ

157,2

0809 40 05

IL

167,2

ZZ

167,2

---

(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’.

---

| 25.7.2009 | EN | Official Journal of the European Union | L 194/3 |
| --- | --- | --- | --- |

25.7.2009

EN

Official Journal of the European Union

L 194/3

---

COMMISSION REGULATION (EC) No 666/2009

of 24 July 2009

amending the representative prices and additional import duties for certain products in the sugar sector fixed by Regulation (EC) No 945/2008 for the 2008/2009 marketing year

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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

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

Whereas:

| (1) | The representative prices and additional duties applicable to imports of white sugar, raw sugar and certain syrups for the 2008/2009 marketing year are fixed by Commission Regulation (EC) No 945/2008 (3). These prices and duties have been last amended by Commission Regulation (EC) No 630/2009 (4). |
| --- | --- |

(1)

The representative prices and additional duties applicable to imports of white sugar, raw sugar and certain syrups for the 2008/2009 marketing year are fixed by Commission Regulation (EC) No 945/2008 (3). These prices and duties have been last amended by Commission Regulation (EC) No 630/2009 (4).

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

(2)

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

HAS ADOPTED THIS REGULATION:

Article 1

The representative prices and additional duties applicable to imports of the products referred to in Article 36 of Regulation (EC) No 951/2006, as fixed by Regulation (EC) No 945/2008 for the 2008/2009, marketing year, are hereby amended as set out in the Annex hereto.

Article 2

This Regulation shall enter into force on 25 July 2009.

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

Done at Brussels, 24 July 2009.

For the Commission

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

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

1

(2)  OJ L 178, 1.7.2006, p. 24.

2

(3)  OJ L 258, 26.9.2008, p. 56.

3

(4)  OJ L 187, 18.7.2009, p. 3.

4

---

ANNEX

Amended representative prices and additional import duties applicable to white sugar, raw sugar and products covered by CN code 1702 90 95 from 25 July 2009

| (EUR) |
| --- |
| CN code | Representative price per 100 kg net of the product concerned | Additional duty per 100 kg net of the product concerned |
| 1701 11 10 (1) | 31,34 | 1,88 |
| 1701 11 90 (1) | 31,34 | 5,86 |
| 1701 12 10 (1) | 31,34 | 1,75 |
| 1701 12 90 (1) | 31,34 | 5,43 |
| 1701 91 00 (2) | 32,59 | 8,94 |
| 1701 99 10 (2) | 32,59 | 4,56 |
| 1701 99 90 (2) | 32,59 | 4,56 |
| 1702 90 95 (3) | 0,33 | 0,33 |

(EUR)

CN code

Representative price per 100 kg net of the product concerned

Additional duty per 100 kg net of the product concerned

1701 11 10 (1)

31,34

1,88

1701 11 90 (1)

31,34

5,86

1701 12 10 (1)

31,34

1,75

1701 12 90 (1)

31,34

5,43

1701 91 00 (2)

32,59

8,94

1701 99 10 (2)

32,59

4,56

1701 99 90 (2)

32,59

4,56

1702 90 95 (3)

0,33

0,33

---

(1)  For the standard quality defined in point III of Annex IV to Regulation (EC) No 1234/2007.

(2)  For the standard quality defined in point II of Annex IV to Regulation (EC) No 1234/2007.

(3)  Per 1 % sucrose content.

---

| 25.7.2009 | EN | Official Journal of the European Union | L 194/5 |
| --- | --- | --- | --- |

25.7.2009

EN

Official Journal of the European Union

L 194/5

---

COMMISSION REGULATION (EC) No 667/2009

of 22 July 2009

entering a name in the register of protected designations of origin and protected geographical indications (Nocciola Romana (PDO))

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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

Whereas:

| (1) | In accordance with Article 6(2) of Regulation (EC) No 510/2006, Italy’s application to register the name ‘Nocciola Romana’ has been published in the Official Journal of the European Union
   (2). |
| --- | --- |

(1)

In accordance with Article 6(2) of Regulation (EC) No 510/2006, Italy’s application to register the name ‘Nocciola Romana’ has been published in the Official Journal of the European Union
   (2).

| (2) | As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, this name should therefore be entered in the register, |
| --- | --- |

(2)

As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, this name should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name contained in the Annex to this Regulation shall be entered in the register.

Article 2

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

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

Done at Brussels, 22 July 2009.

For the Commission

Mariann FISCHER BOEL

Member of the Commission

---

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

1

(2)  OJ C 308, 3.12.2008, p. 19.

2

---

ANNEX

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

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

ITALY

Nocciola Romana (PDO)

---

| 25.7.2009 | EN | Official Journal of the European Union | L 194/7 |
| --- | --- | --- | --- |

25.7.2009

EN

Official Journal of the European Union

L 194/7

---

COMMISSION REGULATION (EC) No 668/2009

of 24 July 2009

implementing Regulation (EC) No 1394/2007 of the European Parliament and of the Council with regard to the evaluation and certification of quality and non-clinical data relating to advanced therapy medicinal products developed by micro, small and medium-sized enterprises

(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 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (1), and in particular Article 18 thereof,

Whereas:

| (1) | It is appropriate, in the framework of Regulation (EC) No 1394/2007, to lay down provisions for the evaluation and certification of quality and non-clinical data submitted by small and medium-sized enterprises to the European Medicines Agency (hereinafter the Agency) in order to give those enterprises an incentive to conduct quality and non-clinical studies on advanced therapy medicinal products. |
| --- | --- |

(1)

It is appropriate, in the framework of Regulation (EC) No 1394/2007, to lay down provisions for the evaluation and certification of quality and non-clinical data submitted by small and medium-sized enterprises to the European Medicines Agency (hereinafter the Agency) in order to give those enterprises an incentive to conduct quality and non-clinical studies on advanced therapy medicinal products.

| (2) | For reasons of coherence and transparency, the definition of micro, small and medium-sized enterprises provided for in Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (2) should apply. |
| --- | --- |

(2)

For reasons of coherence and transparency, the definition of micro, small and medium-sized enterprises provided for in Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (2) should apply.

| (3) | Pursuant to Regulation (EC) No 1394/2007, the certification procedure should be independent from any application for marketing authorisation. Nevertheless, it should also aim at facilitating the evaluation of any future application for clinical trial and marketing authorisation based on the same data. For this reason, the evaluation of an application for certification should be conducted in accordance with the same scientific and technical requirements as those applicable to a marketing authorisation application, as laid down in Annex I to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (3). |
| --- | --- |

(3)

Pursuant to Regulation (EC) No 1394/2007, the certification procedure should be independent from any application for marketing authorisation. Nevertheless, it should also aim at facilitating the evaluation of any future application for clinical trial and marketing authorisation based on the same data. For this reason, the evaluation of an application for certification should be conducted in accordance with the same scientific and technical requirements as those applicable to a marketing authorisation application, as laid down in Annex I to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (3).

| (4) | It should be possible for applicants for certification to provide all or parts of quality and non-clinical data required by Annex I to Directive 2001/83/EC. However, in order to ensure the added value of certifications, it is appropriate to lay down a minimum set of data required for certification. |
| --- | --- |

(4)

It should be possible for applicants for certification to provide all or parts of quality and non-clinical data required by Annex I to Directive 2001/83/EC. However, in order to ensure the added value of certifications, it is appropriate to lay down a minimum set of data required for certification.

| (5) | Within the Agency, the Committee for Advanced Therapies has the appropriate expertise for the examination of quality and non-clinical data relating to advanced therapy medicinal products. It should therefore be responsible for evaluating applications for certification. |
| --- | --- |

(5)

Within the Agency, the Committee for Advanced Therapies has the appropriate expertise for the examination of quality and non-clinical data relating to advanced therapy medicinal products. It should therefore be responsible for evaluating applications for certification.

| (6) | Where necessary, it should be possible for the Committee for Advanced Therapies to make completion of its evaluation subject to a site visit of the premises where the advanced therapy medicinal product is being developed. |
| --- | --- |

(6)

Where necessary, it should be possible for the Committee for Advanced Therapies to make completion of its evaluation subject to a site visit of the premises where the advanced therapy medicinal product is being developed.

| (7) | Applications for certification may relate to combined advanced therapy medicinal products within the meaning of Regulation (EC) No 1394/2007. In such a case, additional requirements should apply in relation to the conformity of the medical device or active implantable medical device contained in the combined product with the essential requirements laid down in Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (4) and Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (5), respectively. |
| --- | --- |

(7)

Applications for certification may relate to combined advanced therapy medicinal products within the meaning of Regulation (EC) No 1394/2007. In such a case, additional requirements should apply in relation to the conformity of the medical device or active implantable medical device contained in the combined product with the essential requirements laid down in Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (4) and Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (5), respectively.

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

(8)

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

HAS ADOPTED THIS REGULATION:

Article 1

Scope

This Regulation shall apply to micro, small and medium-sized enterprises, within the meaning of Recommendation 2003/361/EC, which develop an advanced-therapy medicinal product and are established in the Community.

Article 2

Procedure for evaluation and certification

1.   Applications for the scientific evaluation and certification of quality and non-clinical data relating to an advanced therapy medicinal product shall be submitted to the Agency and shall contain the following:

| (a) | all information necessary to demonstrate that the applicant falls within the scope of this Regulation as set out in Article 1; |
| --- | --- |

(a)

all information necessary to demonstrate that the applicant falls within the scope of this Regulation as set out in Article 1;

| (b) | an indication as to whether the application relates to quality data only or to quality and non-clinical data; |
| --- | --- |

(b)

an indication as to whether the application relates to quality data only or to quality and non-clinical data;

| (c) | a reference to any applications for certification previously submitted for the same advanced therapy medicinal product, an indication as to whether a certificate has been granted or not and an explanation of the added value of the new application and of the differences between the new application and the application previously submitted; |
| --- | --- |

(c)

a reference to any applications for certification previously submitted for the same advanced therapy medicinal product, an indication as to whether a certificate has been granted or not and an explanation of the added value of the new application and of the differences between the new application and the application previously submitted;

| (d) | the relevant fee as provided for in Council Regulation (EC) No 297/95 (6); |
| --- | --- |

(d)

the relevant fee as provided for in Council Regulation (EC) No 297/95 (6);

| (e) | the data referred to in module 3 of Part I of Annex I to Directive 2001/83/EC which is submitted for certification in accordance with the second subparagraph, taking into account the specific requirements laid down in Part IV of that Annex and the scientific guidelines referred to in Article 5. |
| --- | --- |

(e)

the data referred to in module 3 of Part I of Annex I to Directive 2001/83/EC which is submitted for certification in accordance with the second subparagraph, taking into account the specific requirements laid down in Part IV of that Annex and the scientific guidelines referred to in Article 5.

| (f) | where the application relates to both quality data and non-clinical data, the data referred to in module 4 of Part I of Annex I to Directive 2001/83/EC which is submitted for certification in accordance with the third subparagraph, taking into account the specific requirements laid down in Part IV of that Annex and the scientific guidelines referred to in Article 5. |
| --- | --- |

(f)

where the application relates to both quality data and non-clinical data, the data referred to in module 4 of Part I of Annex I to Directive 2001/83/EC which is submitted for certification in accordance with the third subparagraph, taking into account the specific requirements laid down in Part IV of that Annex and the scientific guidelines referred to in Article 5.

For the purposes of point (e) of the first subparagraph, the application shall contain at least the following data:

| (a) | general information and information related to the starting and raw materials; |
| --- | --- |

(a)

general information and information related to the starting and raw materials;

| (b) | manufacturing process of the active substance(s), with the exception of data on process validation; |
| --- | --- |

(b)

manufacturing process of the active substance(s), with the exception of data on process validation;

| (c) | characterisation of the active substance(s), limited to the data necessary to adequately describe the active substance(s); |
| --- | --- |

(c)

characterisation of the active substance(s), limited to the data necessary to adequately describe the active substance(s);

| (d) | control of active substance(s), with the exception of data on the validation of the assays; |
| --- | --- |

(d)

control of active substance(s), with the exception of data on the validation of the assays;

| (e) | description and composition of the finished product. |
| --- | --- |

(e)

description and composition of the finished product.

For the purposes of point (f) of the first subparagraph, the application shall contain at least the following data:

| (a) | primary pharmacodynamic data supporting the rationale for the proposed therapeutic use; |
| --- | --- |

(a)

primary pharmacodynamic data supporting the rationale for the proposed therapeutic use;

| (b) | pharmacokinetics bio-distribution data, if relevant to corroborate the primary pharmacodynamic data; |
| --- | --- |

(b)

pharmacokinetics bio-distribution data, if relevant to corroborate the primary pharmacodynamic data;

| (c) | at least one toxicity study. |
| --- | --- |

(c)

at least one toxicity study.

2.   If the application fulfils the requirements laid down in paragraph 1 the Agency shall acknowledge receipt of a valid application.

3.   The Committee for Advanced Therapies shall evaluate the valid application within 90 days following its acknowledgment of receipt.

For the purposes of that evaluation, the Committee for Advanced Therapies shall, in particular with a view to the subsequent evaluation of any future application for clinical trial and marketing authorisation, determine whether:

| (a) | the quality data submitted and the quality testing methodology followed by the applicant comply with the scientific and technical requirements set out in sections 2.3 and 3 of Part I, in Part IV and, where relevant to quality data, in the Introduction and General Principles of Annex I to Directive 2001/83/EC; |
| --- | --- |

(a)

the quality data submitted and the quality testing methodology followed by the applicant comply with the scientific and technical requirements set out in sections 2.3 and 3 of Part I, in Part IV and, where relevant to quality data, in the Introduction and General Principles of Annex I to Directive 2001/83/EC;

| (b) | where applicable, the non-clinical data and the non-clinical testing methodology followed by the applicant comply with the scientific and technical requirements set out in sections 2.4 and 4 of Part I, in Part IV and, where relevant to non-clinical data, in the Introduction and General Principles of Annex I to Directive 2001/83/EC. |
| --- | --- |

(b)

where applicable, the non-clinical data and the non-clinical testing methodology followed by the applicant comply with the scientific and technical requirements set out in sections 2.4 and 4 of Part I, in Part IV and, where relevant to non-clinical data, in the Introduction and General Principles of Annex I to Directive 2001/83/EC.

4.   Within the period referred to in paragraph 3, the Committee for Advanced Therapies may request the applicant to provide supplementary information within a given time limit.

In that case, the period referred to in paragraph 3 shall be suspended until the supplementary information requested has been provided.

5.   When the Committee for Advanced Therapies has completed its evaluation, the Agency shall inform the applicant accordingly and provide him without delay with the following documents:

| (a) | an evaluation report detailing in particular the reasons for the conclusion reached by the Committee for Advanced Therapies on the application; |
| --- | --- |

(a)

an evaluation report detailing in particular the reasons for the conclusion reached by the Committee for Advanced Therapies on the application;

| (b) | if appropriate on the basis of this evaluation, a certificate identifying the quality and, where applicable, non-clinical data submitted and the corresponding testing methodologies followed by the applicant, which meet the scientific and technical requirements referred to in the second subparagraph of paragraph 3; |
| --- | --- |

(b)

if appropriate on the basis of this evaluation, a certificate identifying the quality and, where applicable, non-clinical data submitted and the corresponding testing methodologies followed by the applicant, which meet the scientific and technical requirements referred to in the second subparagraph of paragraph 3;

| (c) | where deemed appropriate by the Committee for Advanced Therapies, a list of issues for future consideration by the applicant as regards the compliance with the scientific and technical requirements of Annex I to Directive 2001/83/EC of the quality and, where applicable, non-clinical data submitted, and the corresponding testing methodologies followed by the applicant. |
| --- | --- |

(c)

where deemed appropriate by the Committee for Advanced Therapies, a list of issues for future consideration by the applicant as regards the compliance with the scientific and technical requirements of Annex I to Directive 2001/83/EC of the quality and, where applicable, non-clinical data submitted, and the corresponding testing methodologies followed by the applicant.

Article 3

Site visits

The Committee for Advanced Therapies may inform the applicant that a site visit of the premises where the advanced therapy medicinal product concerned is being developed is necessary in order to complete its evaluation in accordance with Article 2. It shall inform the applicant of the objectives of the site visit. If the applicant accepts the conduct of a site visit, it shall be carried out by inspectors from the Member States who hold the appropriate qualifications.

In that case, the time-limit laid down in Article 2(3) shall be suspended until the visit report has been made available to the Committee for Advanced Therapies and to the applicant.

Article 4

Combined advanced therapy medicinal products

1.   Where an application for certification relates to combined advanced therapy medicinal products, the additional requirements set out in paragraphs 2 and 3 shall apply.

2.   The application for certification of data related to a combined advanced therapy medicinal product may include evidence of conformity with the essential requirements referred to in Article 6 of Regulation (EC) No 1394/2007.

3.   The application for certification of data related to a combined advanced therapy medicinal product shall include, where available, the results of the assessment by a notified body in accordance with Directive 93/42/EEC or Directive 90/385/EEC of the medical device part or active implantable medical device part.

The Agency shall recognise the results of that assessment in its evaluation of the data concerning the medicinal product concerned.

The Agency may request the relevant notified body to transmit any information related to the results of its assessment. The notified body shall transmit the information within a period of one month. In that case, the period referred to in Article 2(3) shall be suspended until the information requested has been provided.

4.   If the application does not include the results of the assessment, the Agency may

| (a) | seek an opinion on the conformity of the device part with Annex I to Directive 93/42/EEC or Annex 1 to Directive 90/385/EEC from a notified body identified in conjunction with the applicant, unless the Committee for Advanced Therapies advised by its experts for medical devices decides that involvement of a notįfied body is not required; or |
| --- | --- |

(a)

seek an opinion on the conformity of the device part with Annex I to Directive 93/42/EEC or Annex 1 to Directive 90/385/EEC from a notified body identified in conjunction with the applicant, unless the Committee for Advanced Therapies advised by its experts for medical devices decides that involvement of a notįfied body is not required; or

| (b) | exclude from the evaluation the check of conformity of the medical device with the essential requirements referred to in Article 6 of Regulation (EC) No 1394/2007. |
| --- | --- |

(b)

exclude from the evaluation the check of conformity of the medical device with the essential requirements referred to in Article 6 of Regulation (EC) No 1394/2007.

In the case referred to in point (a), the period referred to in Article 2(3) shall be suspended until the opinion requested has been provided.

In the case referred to in point (b), the evaluation report and any certificate provided shall record the fact that the evaluation excludes the check of conformity of the medical device with the essential requirements. The evaluation report and any certificate provided may also conclude that the interaction and compatibility between the cells or tissues and the medical device cannot be evaluated in the absence of the results of the assessment by a notified body.

Article 5

Scientific guidelines

In assembling the dossier for application for certification, applicants shall take into account the scientific guidelines published by the Agency relating to the minimum quality and non-clinical data set out in the second and third subparagraphs of Article 2(1) for the certification of advanced therapy medicinal products.

Article 6

Report

The Agency shall include in the Annual Report of its activities a section on the experience gained as a result of the application of this Regulation. This section shall in particular contain statistical information on the type and number of applications submitted pursuant to this Regulation.

Article 7

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

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

Done at Brussels, 24 July 2009.

For the Commission

Günter VERHEUGEN

Vice-President

---

(1)  OJ L 324, 10.12.2007, p. 121.

1

(2)  OJ L 124, 20.5.2003, p. 36.

2

(3)  OJ L 311, 28.11.2001, p. 67.

3

(4)  OJ L 169, 12.7.1993, p. 1.

4

(5)  OJ L 189, 20.7.1990, p. 17.

5

(6)  OJ L 35, 15.2.1995, p. 1.

6

---

| 25.7.2009 | EN | Official Journal of the European Union | L 194/11 |
| --- | --- | --- | --- |

25.7.2009

EN

Official Journal of the European Union

L 194/11

---

COMMISSION REGULATION (EC) No 669/2009

of 24 July 2009

implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC

(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 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (1), and in particular Article 15(5) and Article 63(1) thereof,

Having regard to Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (2), and in particular Article 53(1),

Whereas:

| (1) | Regulation (EC) No 882/2004 establishes a harmonised framework of general rules for the organisation of official controls at Community level, including official controls on the introduction of food and feed from third countries. In addition, it provides for a list to be drawn up of feed and food of non-animal origin that is on the basis of a known or emerging risk to be subject to an increased level of official controls at the point of entry into the territories referred to in Annex I thereto (the list). Such an increased level of control should allow, on the one hand, the known or emerging risk to be countered more effectively, and, on the other hand, the collection of accurate monitoring data on the occurrence and prevalence of unfavourable results from laboratory analysis. |
| --- | --- |

(1)

Regulation (EC) No 882/2004 establishes a harmonised framework of general rules for the organisation of official controls at Community level, including official controls on the introduction of food and feed from third countries. In addition, it provides for a list to be drawn up of feed and food of non-animal origin that is on the basis of a known or emerging risk to be subject to an increased level of official controls at the point of entry into the territories referred to in Annex I thereto (the list). Such an increased level of control should allow, on the one hand, the known or emerging risk to be countered more effectively, and, on the other hand, the collection of accurate monitoring data on the occurrence and prevalence of unfavourable results from laboratory analysis.

| (2) | In order to draw up the list, certain criteria, which would allow the identification of a known or emerging risk linked to a specific feed or food of non-animal origin, should be taken into account. |
| --- | --- |

(2)

In order to draw up the list, certain criteria, which would allow the identification of a known or emerging risk linked to a specific feed or food of non-animal origin, should be taken into account.

| (3) | Pending the adoption of a standardised methodology and criteria for the setting up of the list, data resulting from notifications received through the rapid alert system for food and feed (RASFF), as established by Regulation (EC) No 178/2002, reports by the Food and Veterinary Office, reports received from third countries, exchanges of information between the Commission, Member States, and the European Food Safety Authority and scientific assessments, should be considered for the purposes of drawing up and updating the list. |
| --- | --- |

(3)

Pending the adoption of a standardised methodology and criteria for the setting up of the list, data resulting from notifications received through the rapid alert system for food and feed (RASFF), as established by Regulation (EC) No 178/2002, reports by the Food and Veterinary Office, reports received from third countries, exchanges of information between the Commission, Member States, and the European Food Safety Authority and scientific assessments, should be considered for the purposes of drawing up and updating the list.

| (4) | Regulation (EC) No 882/2004 provides that Member States are, for the organisation of the increased level of controls, to designate particular points of entry which have access to the appropriate control facilities for the different types of feed and food. Accordingly, it is appropriate to set out in the present Regulation minimum requirements for designated points of entry in order to ensure a degree of uniformity in the effectiveness of the controls. |
| --- | --- |

(4)

Regulation (EC) No 882/2004 provides that Member States are, for the organisation of the increased level of controls, to designate particular points of entry which have access to the appropriate control facilities for the different types of feed and food. Accordingly, it is appropriate to set out in the present Regulation minimum requirements for designated points of entry in order to ensure a degree of uniformity in the effectiveness of the controls.

| (5) | Regulation (EC) No 882/2004 provides that Member States are, for the organisation of the increased level of controls, to require feed and food business operators, responsible for consignments, to give prior notification of the arrival and nature of such consignments. Accordingly, a model form of common entry document (CED) should be laid down for imports of feed and food of non-animal origin covered by this Regulation, in order to ensure a uniform approach throughout the Community. The CED should be made available to the customs authorities when consignments are declared for the release for free circulation. |
| --- | --- |

(5)

Regulation (EC) No 882/2004 provides that Member States are, for the organisation of the increased level of controls, to require feed and food business operators, responsible for consignments, to give prior notification of the arrival and nature of such consignments. Accordingly, a model form of common entry document (CED) should be laid down for imports of feed and food of non-animal origin covered by this Regulation, in order to ensure a uniform approach throughout the Community. The CED should be made available to the customs authorities when consignments are declared for the release for free circulation.

| (6) | In addition, in order to ensure a certain level of uniformity at Community level with regard to the increased level of official controls, it is appropriate to lay down in this Regulation that those controls should cover documentary, identity and physical checks. |
| --- | --- |

(6)

In addition, in order to ensure a certain level of uniformity at Community level with regard to the increased level of official controls, it is appropriate to lay down in this Regulation that those controls should cover documentary, identity and physical checks.

| (7) | Adequate financial resources should be made available for organising the increased levels of official controls. Therefore, the Member States should collect the fees necessary to cover the costs occasioned by those controls. The calculation of those fees should be in accordance with the criteria laid down in Annex VI to Regulation (EC) No 882/2004. |
| --- | --- |

(7)

Adequate financial resources should be made available for organising the increased levels of official controls. Therefore, the Member States should collect the fees necessary to cover the costs occasioned by those controls. The calculation of those fees should be in accordance with the criteria laid down in Annex VI to Regulation (EC) No 882/2004.

| (8) | Commission Decision 2005/402/EC of 23 May 2005 on emergency measures regarding chilli, chilli products, curcuma and palm oil (3) provides that all consignments of such products are to be accompanied by an analytical report demonstrating that the product does not contain any of the following substances: Sudan I (CAS number 842-07-9), Sudan II (CAS number 3118-97-6), Sudan III (CAS number 85-86-9) or Sudan IV (85-83-6). Since the adoption of those measures, the frequency of the notifications to the RASFF has decreased, which indicates a significant improvement in the situation as regards the presence of Sudan dyes in relevant products. It is therefore appropriate to discontinue the requirement to provide the analytical report for each consignment of imported products laid down in Decision 2005/402/EC and to establish instead a uniform, increased level of controls on those consignments at the point of entry into the Community. Decision 2005/402/EC should therefore be repealed. |
| --- | --- |

(8)

Commission Decision 2005/402/EC of 23 May 2005 on emergency measures regarding chilli, chilli products, curcuma and palm oil (3) provides that all consignments of such products are to be accompanied by an analytical report demonstrating that the product does not contain any of the following substances: Sudan I (CAS number 842-07-9), Sudan II (CAS number 3118-97-6), Sudan III (CAS number 85-86-9) or Sudan IV (85-83-6). Since the adoption of those measures, the frequency of the notifications to the RASFF has decreased, which indicates a significant improvement in the situation as regards the presence of Sudan dyes in relevant products. It is therefore appropriate to discontinue the requirement to provide the analytical report for each consignment of imported products laid down in Decision 2005/402/EC and to establish instead a uniform, increased level of controls on those consignments at the point of entry into the Community. Decision 2005/402/EC should therefore be repealed.

| (9) | Commission Decision 2006/504/EC of 12 July 2006 on special conditions governing certain foodstuffs imported from certain third countries due to contamination risks of these products by aflatoxins (4), provides for an increased frequency of controls (50 % of all consignments) to be carried for the presence of aflatoxins in peanuts originating from Brazil. Since the adoption of those measures, the frequency of the notifications to the RASFF in relation to aflatoxins in peanuts from Brazil has decreased. It is therefore appropriate to discontinue the measures provided for in Decision 2006/504 as regards such commodities, which should instead be subject to a uniform, increased level of controls at the point of entry into the Community. Decision 2006/504/EC should be amended accordingly. |
| --- | --- |

(9)

Commission Decision 2006/504/EC of 12 July 2006 on special conditions governing certain foodstuffs imported from certain third countries due to contamination risks of these products by aflatoxins (4), provides for an increased frequency of controls (50 % of all consignments) to be carried for the presence of aflatoxins in peanuts originating from Brazil. Since the adoption of those measures, the frequency of the notifications to the RASFF in relation to aflatoxins in peanuts from Brazil has decreased. It is therefore appropriate to discontinue the measures provided for in Decision 2006/504 as regards such commodities, which should instead be subject to a uniform, increased level of controls at the point of entry into the Community. Decision 2006/504/EC should be amended accordingly.

| (10) | The application of the minimum requirements for designated points of entry may present practical difficulties for the Member States. Therefore, this Regulation should provide for a transitional period during which those requirements may be progressively implemented. Accordingly, the competent authorities in the Member States should be allowed, during that transitional period, to carry out the required identity and physical checks at control points other than the designated point of entry. In those cases, such control points should comply with the minimum requirements for designated points of entry set out in this Regulation. |
| --- | --- |

(10)

The application of the minimum requirements for designated points of entry may present practical difficulties for the Member States. Therefore, this Regulation should provide for a transitional period during which those requirements may be progressively implemented. Accordingly, the competent authorities in the Member States should be allowed, during that transitional period, to carry out the required identity and physical checks at control points other than the designated point of entry. In those cases, such control points should comply with the minimum requirements for designated points of entry set out in this Regulation.

| (11) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(11)

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

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter

This Regulation lays down rules concerning the increased level of official controls to be carried out pursuant to Article 15(5) of Regulation (EC) No 882/2004 at the points of entry into the territories referred to Annex I thereto, on imports of the feed and food of non-animal origin listed in Annex I to this Regulation.

Article 2

Updates to Annex I

In order to set up and regularly amend the list in Annex I, at least the following sources of information shall be taken into account:

| (a) | data resulting from notifications received through the RASFF; |
| --- | --- |

(a)

data resulting from notifications received through the RASFF;

| (b) | reports and information resulting from the activities of the Food and Veterinary Office; |
| --- | --- |

(b)

reports and information resulting from the activities of the Food and Veterinary Office;

| (c) | reports and information received from third countries; |
| --- | --- |

(c)

reports and information received from third countries;

| (d) | information exchanged between the Commission and Member States, and the European Food Safety Authority; |
| --- | --- |

(d)

information exchanged between the Commission and Member States, and the European Food Safety Authority;

| (e) | scientific assessments, where appropriate. |
| --- | --- |

(e)

scientific assessments, where appropriate.

The list in Annex I shall be reviewed on a regular basis, and at least quarterly.

Article 3

Definitions

For the purposes of this Regulation, the following definitions shall apply:

| (a) | ‘common entry document (CED)’ means the document to be completed by the feed and food business operator or its representative as provided for in Article 6, a model of which is set out in Annex II, and by the competent authority confirming completion of official controls; |
| --- | --- |

(a)

‘common entry document (CED)’ means the document to be completed by the feed and food business operator or its representative as provided for in Article 6, a model of which is set out in Annex II, and by the competent authority confirming completion of official controls;

| (b) | ‘designated point of entry (DPE)’ means the point of entry provided for in the first indent of Article 17(1) of Regulation (EC) No 882/2004, into one of the territories referred to in Annex I thereto; in cases of consignments arriving by sea, which are unloaded for the purposes of being loaded on another vessel for onwards transportation to a port in another Member State, the designated point of entry shall be the latter port; |
| --- | --- |

(b)

‘designated point of entry (DPE)’ means the point of entry provided for in the first indent of Article 17(1) of Regulation (EC) No 882/2004, into one of the territories referred to in Annex I thereto; in cases of consignments arriving by sea, which are unloaded for the purposes of being loaded on another vessel for onwards transportation to a port in another Member State, the designated point of entry shall be the latter port;

| (c) | ‘consignment’ means a quantity of any of the feed or food of non-animal origin listed in Annex I to this Regulation of the same class or description, covered by the same document(s), conveyed by the same means of transport and coming from the same third country or part of such country. |
| --- | --- |

(c)

‘consignment’ means a quantity of any of the feed or food of non-animal origin listed in Annex I to this Regulation of the same class or description, covered by the same document(s), conveyed by the same means of transport and coming from the same third country or part of such country.

Article 4

Minimum requirements for designated points of entry

Without prejudice to Article 19, the designated points of entry shall have at least the following available:

| (a) | a sufficient number of suitably qualified and experienced staff to perform the prescribed checks on consignments; |
| --- | --- |

(a)

a sufficient number of suitably qualified and experienced staff to perform the prescribed checks on consignments;

| (b) | appropriate facilities for the competent authority to undertake the necessary checks; |
| --- | --- |

(b)

appropriate facilities for the competent authority to undertake the necessary checks;

| (c) | detailed instructions regarding sampling for analysis and the sending of such samples for analysis to a laboratory designated pursuant to Article 12(1) of Regulation (EC) No 882/2004 (the designated laboratory); |
| --- | --- |

(c)

detailed instructions regarding sampling for analysis and the sending of such samples for analysis to a laboratory designated pursuant to Article 12(1) of Regulation (EC) No 882/2004 (the designated laboratory);

| (d) | facilities to store consignments (and containerised consignment) in appropriate conditions during the period of detention, where appropriate, awaiting the results of the analysis referred to in point (c), and a sufficient number of storage rooms, including cold stores, in cases where a controlled temperature is required due to the nature of the consignment; |
| --- | --- |

(d)

facilities to store consignments (and containerised consignment) in appropriate conditions during the period of detention, where appropriate, awaiting the results of the analysis referred to in point (c), and a sufficient number of storage rooms, including cold stores, in cases where a controlled temperature is required due to the nature of the consignment;

| (e) | unloading equipment and appropriate equipment for carrying out sampling for analysis; |
| --- | --- |

(e)

unloading equipment and appropriate equipment for carrying out sampling for analysis;

| (f) | the possibility to perform the unloading and the sampling for analysis in a sheltered place, where appropriate; |
| --- | --- |

(f)

the possibility to perform the unloading and the sampling for analysis in a sheltered place, where appropriate;

| (g) | a designated laboratory which can perform the analysis referred to in point (c), situated at a place to which the samples can be transported within a short period of time. |
| --- | --- |

(g)

a designated laboratory which can perform the analysis referred to in point (c), situated at a place to which the samples can be transported within a short period of time.

Article 5

List of designated points of entry

The Member States shall maintain and make publicly available on the Internet for each of the products listed in Annex I an up-to-date list of the designated points of entry. The Member States shall communicate the Internet addresses of these lists to the Commission.

The Commission shall display the national links to those lists on the Commission’s website, for information purposes.

Article 6

Prior notification of consignments

Feed and food business operators or their representatives shall give adequate prior notification of the estimated date and time of physical arrival of the consignment at the designated point of entry and of the nature of the consignment.

For that purpose, they shall complete Part I of the common entry document and transmit that document to the competent authority at the designated point of entry, at least one working day prior to the physical arrival of the consignment.

Article 7

Language of common entry documents

Common entry documents shall be drawn up in the official language, or in one of the official languages, of the Member State where the designated point of entry is located.

However, a Member State may consent to common entry documents being drawn up in another official language of the Community.

Article 8

Increased level of official controls at designated points of entry

1.   The competent authority at the designated point of entry shall carry out without undue delay:

| (a) | documentary checks on all consignments within 2 working days from the time of arrival at the DPE, unless exceptional and unavoidable circumstances arise; |
| --- | --- |

(a)

documentary checks on all consignments within 2 working days from the time of arrival at the DPE, unless exceptional and unavoidable circumstances arise;

| (b) | identity and physical checks, including laboratory analysis, at the frequencies set out in Annex I, and in such a way that it is not possible for feed and food business operators or their representatives to predict whether any particular consignment will be subjected to such checks; the results of physical checks must be available as soon as technically possible. |
| --- | --- |

(b)

identity and physical checks, including laboratory analysis, at the frequencies set out in Annex I, and in such a way that it is not possible for feed and food business operators or their representatives to predict whether any particular consignment will be subjected to such checks; the results of physical checks must be available as soon as technically possible.

2.   After completion of the checks provided for in paragraph 1, the competent authority shall:

| (a) | complete the relevant part of Part II of the common entry document; and the responsible official of the competent authority shall stamp and sign the original of that document; |
| --- | --- |

(a)

complete the relevant part of Part II of the common entry document; and the responsible official of the competent authority shall stamp and sign the original of that document;

| (b) | make and retain a copy of the signed and stamped common entry document. |
| --- | --- |

(b)

make and retain a copy of the signed and stamped common entry document.

The original of the common entry document shall accompany the consignment on its onward transport until it reaches its destination as indicated in the CED.

The competent authority at the DPE may authorise onward transportation of the consignment pending the results of the physical checks. Where authorisation is given, the competent authority at the DPE shall notify the competent authority at the point of destination and appropriate arrangements shall be put in place to ensure that the consignment remains under the continuous control of the competent authorities and cannot be tampered with in any manner pending the results of the physical checks.

In cases where the consignment is transported pending the availability of results from the physical checks, a certified copy of the original CED shall be issued for that purpose.

Article 9

Special circumstances

1.   On request of the Member State concerned, the Commission may authorise the competent authorities of certain designated points of entry operating under specific geographical constraints to carry out physical checks at the premises of a feed and food business operator, provided that the following conditions are met:

| (a) | the efficiency of controls carried out at the DPE is not adversely affected; |
| --- | --- |

(a)

the efficiency of controls carried out at the DPE is not adversely affected;

| (b) | the premises fulfil the requirements indicated in Article 4, as relevant, and are approved for that purpose by the Member State; |
| --- | --- |

(b)

the premises fulfil the requirements indicated in Article 4, as relevant, and are approved for that purpose by the Member State;

| (c) | appropriate arrangements are in place to guarantee that the consignment remains under the continuous control of the competent authorities of the DPE as from the moment of its arrival at the DPE and cannot be tampered with in any manner throughout all checks. |
| --- | --- |

(c)

appropriate arrangements are in place to guarantee that the consignment remains under the continuous control of the competent authorities of the DPE as from the moment of its arrival at the DPE and cannot be tampered with in any manner throughout all checks.

2.   By derogation to Article 8(1), under exceptional circumstances, the decision to list a new product in Annex I may provide that identity and physical checks on consignments of that product can be carried out by the competent authority of the place of destination as indicated in the CED, if appropriate at the premises of the feed and food business operator if the conditions laid down in paragraph 1 (b) and (c) are satisfied, provided that the following conditions are met:

| (a) | the highly perishable nature of the product or the specific characteristics of the packaging are such that the performance of sampling operations at the DPE would inevitably result in a serious risk to food safety or in the product being damaged to an unacceptable extent; |
| --- | --- |

(a)

the highly perishable nature of the product or the specific characteristics of the packaging are such that the performance of sampling operations at the DPE would inevitably result in a serious risk to food safety or in the product being damaged to an unacceptable extent;

| (b) | appropriate cooperation arrangements are put in place by the competent authorities at the DPE and the competent authorities performing the physical checks to ensure that:






  (i) | the consignment cannot be tampered with in any manner throughout all checks; |
| --- | --- | --- |

(b)

appropriate cooperation arrangements are put in place by the competent authorities at the DPE and the competent authorities performing the physical checks to ensure that:

(i)

the consignment cannot be tampered with in any manner throughout all checks;

| (ii) | the reporting requirements laid down in Article 15 are fully met. |
| --- | --- |

(ii)

the reporting requirements laid down in Article 15 are fully met.

Article 10

Release for free circulation

The release for free circulation of consignments shall be subject to the presentation by the feed and food business operator or their representative to the custom authorities of a common entry document or its electronic equivalent duly completed by the competent authority once all controls required in accordance with Article 8(1) have been carried out and favourable results from physical checks, where such checks are required, are known.

Article 11

Obligations of feed and food business operators

In cases where the special characteristics of the consignment so warrant, feed and food business operator or their representative shall make available to the competent authority:

| (a) | sufficient human resources and logistics to unload the consignment, in order that the official controls may take place; |
| --- | --- |

(a)

sufficient human resources and logistics to unload the consignment, in order that the official controls may take place;

| (b) | the appropriate equipment for sampling for analysis as regards special transport and/or specific packaging forms, insofar as such sampling cannot be representatively performed with standard sampling equipment. |
| --- | --- |

(b)

the appropriate equipment for sampling for analysis as regards special transport and/or specific packaging forms, insofar as such sampling cannot be representatively performed with standard sampling equipment.

Article 12

Splitting of consignments

Consignments shall not be split until the increased level of official controls has been completed, and the common entry document has been completed by the competent authority as provided for in Article 8.

In the case of subsequent splitting of the consignment, an authenticated copy of the common entry document shall accompany each part of the consignment until it is released for free circulation.

Article 13

Non-compliance

If the official controls establish non-compliance, the responsible official of the competent authority shall complete Part III of the common entry document and action shall be taken pursuant to Articles 19, 20 and 21 of Regulation (EC) No 882/2004.

Article 14

Fees

1.   Member States shall ensure the collection of fees occasioned by the increased level of official controls provided for in this Regulation in accordance with Article 27(4) of Regulation (EC) No 882/2004, and the criteria laid down in Annex VI to Regulation (EC) No 882/2004.

2.   Feed and food business operators responsible for the consignment or their representatives shall pay the fees referred to in paragraph 1.

Article 15

Reporting to the Commission

1.   Member States shall submit to the Commission a report on consignments, for the purposes of a continuous assessment of the feed and food of non-animal origin listed in Annex I.

That report shall be submitted quarterly by the end of the month following each quarter.

2.   The report shall include the following information:

| (a) | details of each consignment, including:






  (i) | the size in terms of net weight of the consignment; |
| --- | --- | --- |

(a)

details of each consignment, including:

(i)

the size in terms of net weight of the consignment;

| (ii) | the country of origin of each consignment; |
| --- | --- |

(ii)

the country of origin of each consignment;

| (b) | the number of consignments subjected to sampling for analysis; |
| --- | --- |

(b)

the number of consignments subjected to sampling for analysis;

| (c) | the results of the checks as provided for in Article 8(1); |
| --- | --- |

(c)

the results of the checks as provided for in Article 8(1);

3.   The Commission shall compile the reports received pursuant to paragraph 2 and make them available to the Member States.

Article 16

Amendment to Decision 2006/504/EC

Decision 2006/504/EC is amended as follows:

| 1. | in Article 1, point (a) (iii), (iv) and (v) are deleted, |
| --- | --- |

1.

in Article 1, point (a) (iii), (iv) and (v) are deleted,

| 2. | in Article 5, paragraph 2 (a) is replaced by the following:






  ‘(a) | each consignment of foodstuffs from Brazil’, |
| --- | --- | --- |

2.

in Article 5, paragraph 2 (a) is replaced by the following:

‘(a)

each consignment of foodstuffs from Brazil’,

| 3. | in Article 7, paragraph 3 is deleted. |
| --- | --- |

3.

in Article 7, paragraph 3 is deleted.

Article 17

Repeal of Decision 2005/402/EC

Commission Decision 2005/402/EC is repealed.

Article 18

Applicability

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

It shall apply from 25 January 2010.

Article 19

Transitional measures

1.   For a period of five years from the date of entry into force of this Regulation, where a designated point of entry is not equipped with the facilities required to carry out physical checks as provided for in Article 8(1)(b), those checks may be carried out at another point of control in the same Member State, authorised for that purpose by the competent authority, before the goods are declared for release for free circulation, provided that such control point complies with the minimum requirements laid down in Article 4.

2.   Member States shall make publicly available, by electronic publication on their website, a list of the control points authorised in accordance with the first paragraph.

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

Done at Brussels, 24 July 2009.

For the Commission

Androulla VASSILIOU

Member of the Commission

---

(1)  OJ L 165, 30.4.2004, p. 1.

1

(2)  OJ L 31, 1.2.2002, p. 1.

2

(3)  OJ L 135, 28.5.2005, p. 34.

3

(4)  OJ L 199, 21.7.2006, p. 21.

4

---

ANNEX I

A.   Feed and food of non-animal origin subject to an increased level of official controls at the designated point of entry

| Feed and food
  (intended use) | CN code | Country of origin | Hazard | Frequency of physical and identity checks (2)

  (%) |
| --- | --- | --- | --- | --- |
| Groundnuts (peanuts) and derived products (feed and food) | 1202 10 90; 1202 20 00; 2008 11; | Argentina | Aflatoxins | 10 |
| Groundnuts (peanuts) and derived products (feed and food) | 1202 10 90; 1202 20 00; 2008 11; | Brazil | Aflatoxins | 50 |
| Trace elements (feed and food) (3)
   (4) | 2817 00 00; 2820; 2821; 2825 50 00; 2833 25 00; 2833 29 20; 2833 29 80; 2836 99; | China | Cadmium and lead | 50 |
| Groundnuts (peanuts) and derived products (feed and food), in particular peanut butter (food) | 1202 10; 1202 20 00; 2008 11; | Ghana | Aflatoxins | 50 |
| Spices (food):






  — | Capsicum spp (dried fruits thereof, whole or ground, including chillies, chilli powder, cayenne and paprika) |

Feed and food

(intended use)

CN code

Country of origin

Hazard

Frequency of physical and identity checks (2)

(%)

Groundnuts (peanuts) and derived products (feed and food)

1202 10 90; 1202 20 00; 2008 11;

Argentina

Aflatoxins

10

Groundnuts (peanuts) and derived products (feed and food)

1202 10 90; 1202 20 00; 2008 11;

Brazil

Aflatoxins

50

Trace elements (feed and food) (3)
   (4)

2817 00 00; 2820; 2821; 2825 50 00; 2833 25 00; 2833 29 20; 2833 29 80; 2836 99;

China

Cadmium and lead

50

Groundnuts (peanuts) and derived products (feed and food), in particular peanut butter (food)

1202 10; 1202 20 00; 2008 11;

Ghana

Aflatoxins

50

Spices (food):

—

Capsicum spp (dried fruits thereof, whole or ground, including chillies, chilli powder, cayenne and paprika)

| — | Myristica fragrans (nutmeg) |
| --- | --- |

—

Myristica fragrans (nutmeg)

| — | Zingiber officinale (ginger) |
| --- | --- |

—

Zingiber officinale (ginger)

| — | Curcuma longa (turmeric) |
| --- | --- |

—

Curcuma longa (turmeric)

0904 20; 0908 10 00; 0908 20 00; 0910 10 00; 0910 30 00;

India

Aflatoxins

50

Groundnuts (peanuts) and derived products (feed and food)

1202 10 90; 1202 20 00; 2008 11

India

Aflatoxins

10

Melon (egusi) seeds and derived products (5) (food)

ex 1207 99

Nigeria

Aflatoxins

50

Dried vine fruit (food)

0806 20

Uzbekistan

Ochratoxin A

50

Chilli, chilli products, curcuma and palm oil (food)

0904 20 90; 0910 99 60; 0910 30 00; 1511 10 90

All third countries

Sudan dyes

20

Groundnuts (peanuts) and derived products (feed and food)

1202 10 90; 1202 20 00; 2008 11

Vietnam

Aflatoxins

10

Basmati rice for direct human consumption (food)

ex 1006 30

Pakistan

Aflatoxins

50

Basmati rice for direct human consumption (food)

ex 1006 30

India

Aflatoxins

10

Mangos, yard long beans (Vigna sesquipedalis), melon bitter (Momordica charantia), Lauki, (Lagenaria siceraria), peppers and aubergines (food)

ex 0804 50 00; 0708 20 00; 0807 11 00; 0707 00; 0709 60; 0709 30 00

Dominican Republic

Pesticide residues analysed with Multiresidue methods based on CG-MS and LC-MS (1)

50

Bananas

0803 00 11

Dominican Republic

Pesticide residues analysed with Multiresidue methods based on CG-MS and LC-MS (1)

10

Vegetables, fresh, chilled or frozen (peppers, courgettes and tomatoes)

0709 60; 0709 90 70; 0702 00 00

Turkey

Pesticides: methomyl and oxamyl

10

Pears

0808 20 10

Turkey

Pesticide: amitraz

10

Vegetables, fresh, chilled or frozen (food)

| — | yard long beans (Vigna sesquipedalis) |
| --- | --- |

—

yard long beans (Vigna sesquipedalis)

| — | aubergines |
| --- | --- |

—

aubergines

| — | Brassica vegetables |
| --- | --- |

—

Brassica vegetables

0708 20 00; 0709 30 00; 0704;

Thailand

Organo-phosphorus pesticide residues

50

B.   Definitions

For the purposes of this Annex, the following definitions shall apply:

| (a) | ‘chilli’ means fruits of the genus Capsicum dried and crushed or ground falling within CN Code 0904 20 90, in whatever form, intended for human consumption; |
| --- | --- |

(a)

‘chilli’ means fruits of the genus Capsicum dried and crushed or ground falling within CN Code 0904 20 90, in whatever form, intended for human consumption;

| (b) | ‘chilli products’ means curry powder falling within CN Code 0910 99 60, in whatever form, intended for human consumption; |
| --- | --- |

(b)

‘chilli products’ means curry powder falling within CN Code 0910 99 60, in whatever form, intended for human consumption;

| (c) | ‘curcuma’, means curcuma dried and crushed or ground falling within CN Code 0910 30 00, in whatever form, intended for human consumption; |
| --- | --- |

(c)

‘curcuma’, means curcuma dried and crushed or ground falling within CN Code 0910 30 00, in whatever form, intended for human consumption;

| (d) | ‘palm oil’, means palm oil falling within CN Code 1511 10 90, intended for direct human consumption. |
| --- | --- |

(d)

‘palm oil’, means palm oil falling within CN Code 1511 10 90, intended for direct human consumption.

| (e) | ‘Sudan dyes’ refers to the following chemical substances:






  (i) | Sudan I (CAS Number 842-07-9); |
| --- | --- | --- |

(e)

‘Sudan dyes’ refers to the following chemical substances:

(i)

Sudan I (CAS Number 842-07-9);

| (ii) | Sudan II (CAS Number 3118-97-6); |
| --- | --- |

(ii)

Sudan II (CAS Number 3118-97-6);

| (iii) | Sudan III (CAS Number 85-86-9); |
| --- | --- |

(iii)

Sudan III (CAS Number 85-86-9);

| (iv) | Scarlet Red; or Sudan IV (CAS Number 85-83-6). |
| --- | --- |

(iv)

Scarlet Red; or Sudan IV (CAS Number 85-83-6).

---

(1)  In particular residues of: Amitraz, Acephate, Aldicarb, Benomyl, Carbendazim, Chlorfenapyr, Chlorpyrifos, CS2 (Dithiocarbamates), Diafenthiuron, Diazinon, Dichlorvos, Dicofol, Dimethoate, Endosulfan, Fenamidone, Imidacloprid, Malathion, Methamidophos, Methiocarb, Methomyl, Monocrotophos, Omethoate, oxamyl, Profenofos, Propiconazole, thiabendazol, Thiacloprid.

(2)  Where only certain products under any code are required to be examined and no specific subdivision under this code exists in the goods nomenclature, the code is marked ‘Ex’ (for example Ex20079997: only products containing hazelnuts should be included).

(3)  The trace elements referred to in this entry are the trace elements belonging to the functional group of compounds of trace elements referred to in Annex I, 3 b) of Regulation (EC) No 1831/2003 of the European Parliament and of the Council (OJ L 268, 18.10.2003, p. 29).

(4)  The maximum levels established for lead and cadmium in additives belonging to the functional group of compounds of trace elements in Annex I of Directive 2002/32/EC of the European Parliament and of the Council (OJ L 140, 30.5.2002, p. 10) shall be the reference points for action. If the trace elements are labelled as food supplements as defined in Article 2 of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51), the maximum levels set in Regulation (EC) No 1881/2006 shall apply.

(5)  The maximum levels established for aflatoxins in groundnuts and derived products in the Annex to Regulation (EC) 1881/2006 (OJ L 364, 20.12.2006, p. 5) shall be the reference points for action.

---

ANNEX II

COMMON ENTRY DOCUMENT (CED)

Image

Image

Notes for guidance for the CED

| General | : | Complete the document in capital letters. Notes are shown against the relevant box number. |
| --- | --- | --- |

General

:

Complete the document in capital letters. Notes are shown against the relevant box number.

| Part I | This section is to be completed by the feed and food business operator or their representative, unless otherwise indicated. |
| --- | --- |

Part I

This section is to be completed by the feed and food business operator or their representative, unless otherwise indicated.

| Box I.1. | Consignor: name and full address of the natural or legal person (feed and food business operator) dispatching the consignment. Information on telephone and fax numbers or e-mail address is recommended. |
| --- | --- |
| Box I.2. | This box is to be filled in by the authorities of the Designated Point of Entry (DPE) as defined in Article 2. |
| Box I.3. | Consignee: name and full address of the natural or legal person (feed and food business operator) to whom the consignment is destined. Information on telephone and fax numbers or e-mail address is recommended. |
| Box I.4. | Person responsible for the consignment (also agent, declarant or feed and food business operator): the person who is in charge of the consignment when presented to the DPE and makes the necessary declarations to the competent authorities on behalf of the importer. Indicate name and full address. Information on telephone and fax numbers or e-mail address is recommended. |
| Box I.5. | Country of origin: this refers to the country where the commodity is originating from, grown, harvested or produced. |
| Box I.6. | Country from where consigned: this refers to the country where the consignment was placed aboard the means of final transport for the journey to the Community. |
| Box I.7. | Importer: name and full address. Information on telephone and fax numbers or e-mail address is recommended. |
| Box I.8. | Place of destination: delivery address in the Community. Information on telephone and fax numbers or e-mail address is recommended. |
| Box I.9. | Arrival at DPE: give the estimated date on which the consignment is expected to arrive at the DPE. |
| Box I.10. | Documents: indicate the date of issue and the number of official documents accompanying the consignment, as appropriate. |
| Box I.11. | Give full details of the means of arrival transport: for aircraft the flight number, for vessels the ship name, for road vehicles the registration number plate with trailer number if appropriate, for railways the train identity and wagon number. Documentary references: number of airway bill, bill of lading or commercial number for railway or truck. |
| Box I.12. | Description of the commodity: please provide a detailed description of the commodity (including for feed the type). |
| Box I.13. | Commodity or HS code of the Harmonized System of the World Customs Organization. |
| Box I.14. | Gross weight: overall weight in kg. This is defined as the aggregate mass of the products and of the immediate containers and all their packaging, but excluding transport containers and other transport equipment.
  Net weight: weight of actual product in kg, excluding packaging. This is defined as the mass of the products themselves without immediate containers or any packaging. |
| Box I.15. | Number of packages. |
| Box I.16. | Temperature: tick the appropriate mode of transport/storage temperature. |
| Box I.17. | Type of packaging: identify the type of packaging of products. |
| Box I.18. | Commodity intended for: tick the appropriate box depending on whether the commodity is destined for human consumption without prior sorting or other physical treatment (in this case tick ‘human consumption’) or is intended for human consumption after such treatment (tick ‘further process’ in this case), or is intended for use as ‘feedingstuff’ (in this case tick ‘feedingstuffs’). |
| Box I.19. | Give all seal and container identification numbers where relevant. |
| Box I.20. | Transfer to a control point: During the transitional period referred to in Art. 17, the DPE shall tick this box to allow onward transportation to another control point. |
| Box I.21. | Not applicable. |
| Box I.22. | For import: this box is to be ticked in case the consignment is intended for import (Article 8). |
| Box I.23. | Not applicable. |
| Box I.24. | Tick the appropriate means of transport. |

Box I.1.

Consignor: name and full address of the natural or legal person (feed and food business operator) dispatching the consignment. Information on telephone and fax numbers or e-mail address is recommended.

Box I.2.

This box is to be filled in by the authorities of the Designated Point of Entry (DPE) as defined in Article 2.

Box I.3.

Consignee: name and full address of the natural or legal person (feed and food business operator) to whom the consignment is destined. Information on telephone and fax numbers or e-mail address is recommended.

Box I.4.

Person responsible for the consignment (also agent, declarant or feed and food business operator): the person who is in charge of the consignment when presented to the DPE and makes the necessary declarations to the competent authorities on behalf of the importer. Indicate name and full address. Information on telephone and fax numbers or e-mail address is recommended.

Box I.5.

Country of origin: this refers to the country where the commodity is originating from, grown, harvested or produced.

Box I.6.

Country from where consigned: this refers to the country where the consignment was placed aboard the means of final transport for the journey to the Community.

Box I.7.

Importer: name and full address. Information on telephone and fax numbers or e-mail address is recommended.

Box I.8.

Place of destination: delivery address in the Community. Information on telephone and fax numbers or e-mail address is recommended.

Box I.9.

Arrival at DPE: give the estimated date on which the consignment is expected to arrive at the DPE.

Box I.10.

Documents: indicate the date of issue and the number of official documents accompanying the consignment, as appropriate.

Box I.11.

Give full details of the means of arrival transport: for aircraft the flight number, for vessels the ship name, for road vehicles the registration number plate with trailer number if appropriate, for railways the train identity and wagon number. Documentary references: number of airway bill, bill of lading or commercial number for railway or truck.

Box I.12.

Description of the commodity: please provide a detailed description of the commodity (including for feed the type).

Box I.13.

Commodity or HS code of the Harmonized System of the World Customs Organization.

Box I.14.

Gross weight: overall weight in kg. This is defined as the aggregate mass of the products and of the immediate containers and all their packaging, but excluding transport containers and other transport equipment.

Net weight: weight of actual product in kg, excluding packaging. This is defined as the mass of the products themselves without immediate containers or any packaging.

Box I.15.

Number of packages.

Box I.16.

Temperature: tick the appropriate mode of transport/storage temperature.

Box I.17.

Type of packaging: identify the type of packaging of products.

Box I.18.

Commodity intended for: tick the appropriate box depending on whether the commodity is destined for human consumption without prior sorting or other physical treatment (in this case tick ‘human consumption’) or is intended for human consumption after such treatment (tick ‘further process’ in this case), or is intended for use as ‘feedingstuff’ (in this case tick ‘feedingstuffs’).

Box I.19.

Give all seal and container identification numbers where relevant.

Box I.20.

Transfer to a control point: During the transitional period referred to in Art. 17, the DPE shall tick this box to allow onward transportation to another control point.

Box I.21.

Not applicable.

Box I.22.

For import: this box is to be ticked in case the consignment is intended for import (Article 8).

Box I.23.

Not applicable.

Box I.24.

Tick the appropriate means of transport.

| Part II | This section is to be completed by the competent authority. |
| --- | --- |

Part II

This section is to be completed by the competent authority.

| Box II.1. | Use the same reference number as in Box I.2. |
| --- | --- |
| Box II.2. | For use by customs services if necessary. |
| Box II.3. | Documentary check: to be completed for all consignments. |
| Box II.4. | The DPE authority shall indicate whether the consignment is selected for physical checks, which during the transitional period referred to in Art. 17 can be performed by a different control point. |
| Box II.5. | The DPE authority shall indicate, during the transitional period referred to in Art. 17, following a satisfactory documentary/identity check, to which control point the consignment can be transported for a physical check. |
| Box II.6. | Indicate clearly the action to be carried out in case of rejection of the consignment due to the unsatisfactory outcome of the documentary or identity checks. The address of the destination establishment in case of ‘Re-dispatching’, ‘Destruction’, ‘Transformation’ and ‘Use for other purpose’ should be entered in Box II.7. |
| Box II.7. | Give as appropriate approval number and address (or ship name and port) for all destinations where further control of the consignment is required, for example for Box II.6, ‘Re-dispatching’, ‘Destruction’, ‘Transformation’ or ‘Use for other purpose’. |
| Box II.8. | Put here the official stamp of the DPE competent authority. |
| Box II.9. | Signature of the official responsible of the DPE competent authority. |
| Box II.10. | Not applicable. |
| Box II.11. | The DPE authority or, during the transitional period referred to in Article 17, the competent authority of the control point, indicates here the results of the identity checks. |
| Box II.12. | The DPE authority or, during the transitional period referred to in Article 17, the competent authority of the control point, indicates here the results of the physical checks. |
| Box II.13. | The DPE authority or, during the transitional period referred to in Article 17, the competent authority of the control point, indicates here the results of the laboratory test. Complete this box with the category of substance or pathogen for which a laboratory test is carried out. |
| Box II.14. | This box is to be used for all consignments to be released for free circulation within the Community. |
| Box II.15. | Not applicable. |
| Box II.16. | Indicate clearly the action to be carried out in case of rejection of the consignment due to the unsatisfactory outcome of the physical checks. The address of the destination establishment in case of ‘Re-dispatching’, ‘Destruction’, ‘Transformation’ and ‘Use for other purpose’ must be entered in Box II.18. |
| Box II.17. | Reasons for refusal: use as appropriate to add relevant information. Tick the appropriate box. |
| Box II.18. | Give as appropriate approval number and address (or ship name and port) for all destinations where further control of the consignment is required, for example, for Box II.16, ‘Re-dispatching’, ‘Destruction’, ‘Transformation’ or ‘Use for other purpose’. |
| Box II.19. | Use this box when the original seal recorded on a consignment is destroyed on opening the container. A consolidated list of all seals that have been used for this purpose must be kept. |
| Box II.20. | Put here the official stamp of the DPE authority or, during the transitional period referred to in Article 17, of the control point’s competent authority. |
| Box II.21. | Signature of the official responsible of the DPE authority or, during the transitional period referred to in Article 17, of the control point’s competent authority. |

Box II.1.

Use the same reference number as in Box I.2.

Box II.2.

For use by customs services if necessary.

Box II.3.

Documentary check: to be completed for all consignments.

Box II.4.

The DPE authority shall indicate whether the consignment is selected for physical checks, which during the transitional period referred to in Art. 17 can be performed by a different control point.

Box II.5.

The DPE authority shall indicate, during the transitional period referred to in Art. 17, following a satisfactory documentary/identity check, to which control point the consignment can be transported for a physical check.

Box II.6.

Indicate clearly the action to be carried out in case of rejection of the consignment due to the unsatisfactory outcome of the documentary or identity checks. The address of the destination establishment in case of ‘Re-dispatching’, ‘Destruction’, ‘Transformation’ and ‘Use for other purpose’ should be entered in Box II.7.

Box II.7.

Give as appropriate approval number and address (or ship name and port) for all destinations where further control of the consignment is required, for example for Box II.6, ‘Re-dispatching’, ‘Destruction’, ‘Transformation’ or ‘Use for other purpose’.

Box II.8.

Put here the official stamp of the DPE competent authority.

Box II.9.

Signature of the official responsible of the DPE competent authority.

Box II.10.

Not applicable.

Box II.11.

The DPE authority or, during the transitional period referred to in Article 17, the competent authority of the control point, indicates here the results of the identity checks.

Box II.12.

The DPE authority or, during the transitional period referred to in Article 17, the competent authority of the control point, indicates here the results of the physical checks.

Box II.13.

The DPE authority or, during the transitional period referred to in Article 17, the competent authority of the control point, indicates here the results of the laboratory test. Complete this box with the category of substance or pathogen for which a laboratory test is carried out.

Box II.14.

This box is to be used for all consignments to be released for free circulation within the Community.

Box II.15.

Not applicable.

Box II.16.

Indicate clearly the action to be carried out in case of rejection of the consignment due to the unsatisfactory outcome of the physical checks. The address of the destination establishment in case of ‘Re-dispatching’, ‘Destruction’, ‘Transformation’ and ‘Use for other purpose’ must be entered in Box II.18.

Box II.17.

Reasons for refusal: use as appropriate to add relevant information. Tick the appropriate box.

Box II.18.

Give as appropriate approval number and address (or ship name and port) for all destinations where further control of the consignment is required, for example, for Box II.16, ‘Re-dispatching’, ‘Destruction’, ‘Transformation’ or ‘Use for other purpose’.

Box II.19.

Use this box when the original seal recorded on a consignment is destroyed on opening the container. A consolidated list of all seals that have been used for this purpose must be kept.

Box II.20.

Put here the official stamp of the DPE authority or, during the transitional period referred to in Article 17, of the control point’s competent authority.

Box II.21.

Signature of the official responsible of the DPE authority or, during the transitional period referred to in Article 17, of the control point’s competent authority.

| Part III | This section is to be completed by the competent authority. |
| --- | --- |

Part III

This section is to be completed by the competent authority.

| Box III.1. | Details on re-dispatching: the DPE authority or, during the transitional period referred to in Article 17., the competent authority of the control point, indicates the means of transport used, its identification, the country of destination and the date of re-dispatching, as soon as they are known. |
| --- | --- |
| Box III.2. | Follow-up: indicate the local competent authority unit responsible, as appropriate, for the supervision in case of ‘Destruction’, ‘Transformation’ or ‘Use for other purpose’ of the consignment. This competent authority shall report here the result of the arrival of the consignment and the correspondence. |
| Box III.3. | Signature of the official responsible for the DPE authority or, during the transitional period referred to in Article 17, the control point, in case of ‘Re-dispatching’. Signature of the official responsible for the local competent authority in case of ‘Destruction’, ‘Transformation’ or ‘Use for other purpose’. |

Box III.1.

Details on re-dispatching: the DPE authority or, during the transitional period referred to in Article 17., the competent authority of the control point, indicates the means of transport used, its identification, the country of destination and the date of re-dispatching, as soon as they are known.

Box III.2.

Follow-up: indicate the local competent authority unit responsible, as appropriate, for the supervision in case of ‘Destruction’, ‘Transformation’ or ‘Use for other purpose’ of the consignment. This competent authority shall report here the result of the arrival of the consignment and the correspondence.

Box III.3.

Signature of the official responsible for the DPE authority or, during the transitional period referred to in Article 17, the control point, in case of ‘Re-dispatching’. Signature of the official responsible for the local competent authority in case of ‘Destruction’, ‘Transformation’ or ‘Use for other purpose’.

---

| 25.7.2009 | EN | Official Journal of the European Union | L 194/22 |
| --- | --- | --- | --- |

25.7.2009

EN

Official Journal of the European Union

L 194/22

---

COMMISSION REGULATION (EC) No 670/2009

of 24 July 2009

laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 as regards public intervention by invitation to tender for the purchase of durum wheat or paddy rice, and amending Regulations (EC) No 428/2008 and (EC) No 687/2008

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 43(a), (c) and (k), in conjunction with Article 4 thereof,

Whereas:

| (1) | Pursuant to Article 13(3) and Article 18(2) of Regulation (EC) No 1234/2007, as amended by Council Regulation (EC) No 72/2009 (2), the Commission may decide, as from 1 July 2009 for durum wheat and 1 September 2009 for paddy rice, on public intervention if the market situation and, particularly, trends in market prices so justify it. There is a need to lay down the conditions under which public intervention may occur, in the event of the Commission deciding that such intervention is necessary and to reiterate which authorities are competent, in this area, in the Member States, in accordance with the provisions of Commission Regulation (EC) No 884/2006 of 21 June 2006 laying down detailed rules for the application of Council Regulation (EC) No 1290/2005 as regards the financing by the European Agricultural Guarantee Fund (EAGF) of intervention measures in the form of public storage operations and the accounting of public storage operations by the paying agencies of the Member States (3), by specifying that such authorities shall intervene, for the purposes of this Regulation, as ‘intervention agencies’, including when paying agencies act directly. |
| --- | --- |

(1)

Pursuant to Article 13(3) and Article 18(2) of Regulation (EC) No 1234/2007, as amended by Council Regulation (EC) No 72/2009 (2), the Commission may decide, as from 1 July 2009 for durum wheat and 1 September 2009 for paddy rice, on public intervention if the market situation and, particularly, trends in market prices so justify it. There is a need to lay down the conditions under which public intervention may occur, in the event of the Commission deciding that such intervention is necessary and to reiterate which authorities are competent, in this area, in the Member States, in accordance with the provisions of Commission Regulation (EC) No 884/2006 of 21 June 2006 laying down detailed rules for the application of Council Regulation (EC) No 1290/2005 as regards the financing by the European Agricultural Guarantee Fund (EAGF) of intervention measures in the form of public storage operations and the accounting of public storage operations by the paying agencies of the Member States (3), by specifying that such authorities shall intervene, for the purposes of this Regulation, as ‘intervention agencies’, including when paying agencies act directly.

| (2) | In order to ensure that the public intervention system operates as simply and efficiently as possible, the rules relating to the approval of intervention centres by intervention agencies in the Member States should be defined, and the provisions relating to such approval should be decided upon. To this end, the conditions necessary for the approval of storage premises at intervention centres should be defined. |
| --- | --- |

(2)

In order to ensure that the public intervention system operates as simply and efficiently as possible, the rules relating to the approval of intervention centres by intervention agencies in the Member States should be defined, and the provisions relating to such approval should be decided upon. To this end, the conditions necessary for the approval of storage premises at intervention centres should be defined.

| (3) | The conditions under which offers of durum wheat and paddy rice sent for intervention can be considered admissible, and the conditions for the take-over of products by such agencies must be as uniform as possible throughout the Community. In order to ensure that all operators are treated equally, the procedures applicable to purchases and, specifically, the admissibility of bids, acceptances and checks relating thereto should therefore be defined. |
| --- | --- |

(3)

The conditions under which offers of durum wheat and paddy rice sent for intervention can be considered admissible, and the conditions for the take-over of products by such agencies must be as uniform as possible throughout the Community. In order to ensure that all operators are treated equally, the procedures applicable to purchases and, specifically, the admissibility of bids, acceptances and checks relating thereto should therefore be defined.

| (4) | If storage premises at an approved intervention centre, situated in a Member State other than that in which the main activity of the operator is carried out, allow operators to deliver their products as cheaply as possible, the said operators should have the possibility of submitting their tenders in the Member State concerned. In order to avoid these operators being subject to additional administrative restrictions, they should therefore be authorised to carry out the formalities relating to the tenders using their VAT registration number in the Member State in which they carry out their main activity and be allowed to lodge, in order to substantiate their bid, a security obtained in the said Member State. |
| --- | --- |

(4)

If storage premises at an approved intervention centre, situated in a Member State other than that in which the main activity of the operator is carried out, allow operators to deliver their products as cheaply as possible, the said operators should have the possibility of submitting their tenders in the Member State concerned. In order to avoid these operators being subject to additional administrative restrictions, they should therefore be authorised to carry out the formalities relating to the tenders using their VAT registration number in the Member State in which they carry out their main activity and be allowed to lodge, in order to substantiate their bid, a security obtained in the said Member State.

| (5) | In order to ensure simplified and satisfactory management of the intervention measure, a batch presented should be homogenous and, in the case of rice, composed of rice of the same variety. A minimum quantity should also be established, below which the intervention agency is not obliged to accept the bid, but nevertheless taking into account the fact that a minimum additional tonnage may prove necessary in order to take into account the conditions and practices of the wholesale trade or environmental regulations in force in a Member State. In order to provide operators with information regarding applicable minimum amounts, intervention agencies should specify these minimum amounts in each tender notice that they publish and, if necessary, establish such amounts at a level higher than that laid down in this Regulation. |
| --- | --- |

(5)

In order to ensure simplified and satisfactory management of the intervention measure, a batch presented should be homogenous and, in the case of rice, composed of rice of the same variety. A minimum quantity should also be established, below which the intervention agency is not obliged to accept the bid, but nevertheless taking into account the fact that a minimum additional tonnage may prove necessary in order to take into account the conditions and practices of the wholesale trade or environmental regulations in force in a Member State. In order to provide operators with information regarding applicable minimum amounts, intervention agencies should specify these minimum amounts in each tender notice that they publish and, if necessary, establish such amounts at a level higher than that laid down in this Regulation.

| (6) | Durum wheat and paddy rice whose quality does not permit suitable further use or storage should not be accepted for intervention. The methods necessary for establishing the quality of durum wheat and paddy rice must, to this end, be defined. |
| --- | --- |

(6)

Durum wheat and paddy rice whose quality does not permit suitable further use or storage should not be accepted for intervention. The methods necessary for establishing the quality of durum wheat and paddy rice must, to this end, be defined.

| (7) | Durum wheat is a cereal covered by minimum quality criteria for human consumption and must satisfy the health standards laid down by Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (4). These standards should apply when the product concerned is taken over under the present intervention scheme. |
| --- | --- |

(7)

Durum wheat is a cereal covered by minimum quality criteria for human consumption and must satisfy the health standards laid down by Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (4). These standards should apply when the product concerned is taken over under the present intervention scheme.

| (8) | The risks inherent in exceeding the maximum admissible contaminant thresholds can be identified by the paying agencies or intervention agencies on the basis of information received from bidders and their own analysis criteria. In order to limit the financial costs, there is therefore justification for requiring analyses, under the responsibility of the agencies prior to the taking-over of products, only on the basis of a risk analysis enabling the quality of the products on entry into the intervention scheme to be guaranteed. Where a Member State takes a decision at the time of purchase of a product and that decision is inadequate in the light of the risk analysis required by these rules, that Member State should however be directly liable if it later emerges that the product did not comply with the minimum standards prescribed. Such a decision would not make it possible to guarantee the quality of the product and, therefore, ensure its proper preservation. Consequently, the circumstances under which a Member State is to be held liable should be specified. |
| --- | --- |

(8)

The risks inherent in exceeding the maximum admissible contaminant thresholds can be identified by the paying agencies or intervention agencies on the basis of information received from bidders and their own analysis criteria. In order to limit the financial costs, there is therefore justification for requiring analyses, under the responsibility of the agencies prior to the taking-over of products, only on the basis of a risk analysis enabling the quality of the products on entry into the intervention scheme to be guaranteed. Where a Member State takes a decision at the time of purchase of a product and that decision is inadequate in the light of the risk analysis required by these rules, that Member State should however be directly liable if it later emerges that the product did not comply with the minimum standards prescribed. Such a decision would not make it possible to guarantee the quality of the product and, therefore, ensure its proper preservation. Consequently, the circumstances under which a Member State is to be held liable should be specified.

| (9) | When fixing the minimum quality of paddy rice, consideration should be given in particular to weather conditions in the rice-growing areas of the Community. |
| --- | --- |

(9)

When fixing the minimum quality of paddy rice, consideration should be given in particular to weather conditions in the rice-growing areas of the Community.

| (10) | The checks to ensure that the products offered are actually present at the storage premises nominated by the bidder and that the requirements established regarding the weight and quality of goods offered are complied with should be precisely laid down. A distinction should be made between, on the one hand, acceptance of the goods offered after the quantity and compliance with the minimum quality requirements have been checked and, on the other hand, fixing the price to be paid to the bidder after the necessary tests have been carried out to identify the precise characteristics of each lot based on representative samples. |
| --- | --- |

(10)

The checks to ensure that the products offered are actually present at the storage premises nominated by the bidder and that the requirements established regarding the weight and quality of goods offered are complied with should be precisely laid down. A distinction should be made between, on the one hand, acceptance of the goods offered after the quantity and compliance with the minimum quality requirements have been checked and, on the other hand, fixing the price to be paid to the bidder after the necessary tests have been carried out to identify the precise characteristics of each lot based on representative samples.

| (11) | To allow sound management of this intervention measure, tenders for durum wheat and rice are firm and definitive. They may not therefore be amended or withdrawn and it is necessary for the submission of bids to be subject to the lodging of a security and to specify the means of its release and possible forfeit to the Community budget in the event of non-compliance with certain conditions regarding the admissibility of the said offers. |
| --- | --- |

(11)

To allow sound management of this intervention measure, tenders for durum wheat and rice are firm and definitive. They may not therefore be amended or withdrawn and it is necessary for the submission of bids to be subject to the lodging of a security and to specify the means of its release and possible forfeit to the Community budget in the event of non-compliance with certain conditions regarding the admissibility of the said offers.

| (12) | Article 18(2) and (4)(a) of Regulation (EC) No 1234/2007 states that the intervention price of durum wheat is fixed by the Commission by means of tendering procedures, without prejudice to price increases and reductions for quality purposes. These price variations linked to the main quality criteria for durum wheat need to be specified. |
| --- | --- |

(12)

Article 18(2) and (4)(a) of Regulation (EC) No 1234/2007 states that the intervention price of durum wheat is fixed by the Commission by means of tendering procedures, without prejudice to price increases and reductions for quality purposes. These price variations linked to the main quality criteria for durum wheat need to be specified.

| (13) | Article 18(4)(b) of Regulation (EC) No 1234/2007 states that the intervention price is fixed for paddy rice of a specific standard quality defined in point A of Annex IV to that Regulation and that, if the quality of the rice offered for intervention differs from that standard quality, the intervention price is to be adjusted by applying price increases or reductions. The application of such increases or reductions should reflect price differences observed on the paddy rice market for quality reasons. To this end, the basic characteristics of paddy rice should be taken into account, thereby allowing an objective assessment of its quality to be made; an assessment of moisture content, milling yield and grain defects, using simple and effective methods, meets this requirement. |
| --- | --- |

(13)

Article 18(4)(b) of Regulation (EC) No 1234/2007 states that the intervention price is fixed for paddy rice of a specific standard quality defined in point A of Annex IV to that Regulation and that, if the quality of the rice offered for intervention differs from that standard quality, the intervention price is to be adjusted by applying price increases or reductions. The application of such increases or reductions should reflect price differences observed on the paddy rice market for quality reasons. To this end, the basic characteristics of paddy rice should be taken into account, thereby allowing an objective assessment of its quality to be made; an assessment of moisture content, milling yield and grain defects, using simple and effective methods, meets this requirement.

| (14) | For the purposes of harmonisation, checks on intervention stock should be carried out under the conditions set out in Article 2 of Regulation (EC) No 884/2006. |
| --- | --- |

(14)

For the purposes of harmonisation, checks on intervention stock should be carried out under the conditions set out in Article 2 of Regulation (EC) No 884/2006.

| (15) | For the purposes of ensuring the efficient management of the system, the information required by the Commission should be sent electronically and communicated on the basis of methods made available to Member States by the Commission. |
| --- | --- |

(15)

For the purposes of ensuring the efficient management of the system, the information required by the Commission should be sent electronically and communicated on the basis of methods made available to Member States by the Commission.

| (16) | The provisions relating to the rice sector made in this Regulation replace those currently in force and made in Commission Regulation (EC) No 489/2005 of 29 March 2005 laying down detailed rules for implementing Council Regulation (EC) No 1785/2003 as regards determining the intervention centres and the taking over of paddy rice by the intervention agencies (5). However, in order to harmonise the rules applying to rice and durum wheat, it is appropriate not to repeat certain provisions contained in Regulation (EC) No 489/2005. |
| --- | --- |

(16)

The provisions relating to the rice sector made in this Regulation replace those currently in force and made in Commission Regulation (EC) No 489/2005 of 29 March 2005 laying down detailed rules for implementing Council Regulation (EC) No 1785/2003 as regards determining the intervention centres and the taking over of paddy rice by the intervention agencies (5). However, in order to harmonise the rules applying to rice and durum wheat, it is appropriate not to repeat certain provisions contained in Regulation (EC) No 489/2005.

| (17) | The provisions relating to durum wheat made in this Regulation replace those currently in force and made in Commission Regulation (EC) No 428/2008 of 8 May 2008 on determining the intervention centres for cereals (6). Provision should therefore be made for these no longer to apply to durum wheat as of 1 July 2009. |
| --- | --- |

(17)

The provisions relating to durum wheat made in this Regulation replace those currently in force and made in Commission Regulation (EC) No 428/2008 of 8 May 2008 on determining the intervention centres for cereals (6). Provision should therefore be made for these no longer to apply to durum wheat as of 1 July 2009.

| (18) | The provisions relating to durum wheat made in this Regulation replace those currently in force and made in Commission Regulation (EC) No 687/2008 of 18 July 2008 establishing procedures for the taking-over of cereals by intervention agencies or paying agencies and laying down methods of analysis for determining the quality of cereals (7). Provision should therefore be made for these no longer to apply to durum wheat as of 1 July 2009. |
| --- | --- |

(18)

The provisions relating to durum wheat made in this Regulation replace those currently in force and made in Commission Regulation (EC) No 687/2008 of 18 July 2008 establishing procedures for the taking-over of cereals by intervention agencies or paying agencies and laying down methods of analysis for determining the quality of cereals (7). Provision should therefore be made for these no longer to apply to durum wheat as of 1 July 2009.

| (19) | Regulations (EC) No 428/2008 and (EC) No 687/2008 should therefore be amended and Regulation (EC) No 489/2005 repealed. |
| --- | --- |

(19)

Regulations (EC) No 428/2008 and (EC) No 687/2008 should therefore be amended and Regulation (EC) No 489/2005 repealed.

| (20) | In accordance with Article 8 of Regulation (EC) No 72/2009, the new provisions relating to public intervention measures made in Regulation (EC) No 1234/2007 are to apply as of 1 July 2009 as regards durum wheat and 1 September 2009 as regards the rice sector. The detailed rules for the application of these measures should therefore apply as of the same dates. |
| --- | --- |

(20)

In accordance with Article 8 of Regulation (EC) No 72/2009, the new provisions relating to public intervention measures made in Regulation (EC) No 1234/2007 are to apply as of 1 July 2009 as regards durum wheat and 1 September 2009 as regards the rice sector. The detailed rules for the application of these measures should therefore apply as of the same dates.

| (21) | The Management Committee for the Common Organisation of Agricultural Markets has not delivered an opinion within the time limit set by its Chair, |
| --- | --- |

(21)

The Management Committee for the Common Organisation of Agricultural Markets has not delivered an opinion within the time limit set by its Chair,

HAS ADOPTED THIS REGULATION:

CHAPTER I

PROVISIONS COMMON TO THE APPROVAL OF INTERVENTION CENTRES, PURCHASES AND BIDS

SECTION 1

GENERAL RULES

Article 1

Scope and definitions

1.   This Regulation establishes, for the durum wheat and rice sectors, the detailed rules of application governing public intervention buying-in, as provided for in Article 13(3) and in Article 18(2) of Regulation (EC) No 1234/2007.

2.   The buying-in referred to in paragraph 1 is carried out by the paying agencies or agencies approved by them, in accordance with Article 2(1) of Regulation (EC) No 884/2006, hereinafter referred to as ‘intervention agencies’.

Article 2

Appointment and approval of intervention centres

1.   The intervention centres to be designated by the Commission, in accordance with Article 41 of Regulation (EC) No 1234/2007, shall be subject to prior approval by the intervention agencies, pursuant to the provisions of this Regulation and the rules laid down in Regulation (EC) No 884/2006, particularly with regard to responsibility and checks, in accordance with Article 2 of that Regulation.

2.   Before an intervention centre can be approved, the intervention agencies shall ensure that the storage premises at that centre meet at least the following standards:

| (a) | a storage capacity of at least 20 000 tonnes for durum wheat or 10 000 tonnes for rice, for all storage premises at that centre; |
| --- | --- |

(a)

a storage capacity of at least 20 000 tonnes for durum wheat or 10 000 tonnes for rice, for all storage premises at that centre;

| (b) | a minimum stock exit capacity to allow, for each storage site, the removal of at least 5 % of the storage capacity per working day, or 1 000 tonnes for durum wheat and 500 tonnes for rice. |
| --- | --- |

(b)

a minimum stock exit capacity to allow, for each storage site, the removal of at least 5 % of the storage capacity per working day, or 1 000 tonnes for durum wheat and 500 tonnes for rice.

3.   The information relating to the list of intervention centres and their storage premises, designated by the Commission in accordance with Article 41 of Regulation (EC) No 1234/2007, shall be amended and made available to Member States and the public in accordance with Articles 23 and 24 of this Regulation.

SECTION 2

PROCEDURE FOR THE PURCHASE OF DURUM WHEAT OR PADDY RICE BY TENDER

Article 3

Purchases

1.   By means of a notice of call for tender, the intervention agencies shall purchase durum wheat or paddy rice following the opening of the tender by means of a Regulation adopted by the Commission, hereinafter referred to as ‘Regulation opening the tendering procedure’, in accordance with the procedure referred to in Article 195(2) of Regulation (EC) No 1234/2007.

2.   The Regulation opening the tendering procedure shall state, in particular:

| (a) | the name of the product, with its CN code; |
| --- | --- |

(a)

the name of the product, with its CN code;

| (b) | the dates of the tenders; |
| --- | --- |

(b)

the dates of the tenders;

| (c) | the deadline (date and time) for the submission of bids; |
| --- | --- |

(c)

the deadline (date and time) for the submission of bids;

| (d) | the closing date of the tendering period; |
| --- | --- |

(d)

the closing date of the tendering period;

| (e) | the Member State(s) or region(s) concerned, in the event of the second subparagraph of Article 18(2) of Regulation (EC) No 1234/2007 applying. |
| --- | --- |

(e)

the Member State(s) or region(s) concerned, in the event of the second subparagraph of Article 18(2) of Regulation (EC) No 1234/2007 applying.

3.   With regard to paddy rice, the tender may be restricted to one or several types of rice as defined in Annex III, Part I, I.2 to Regulation (EC) No 1234/2007 (‘round grain rice’, ‘medium grain rice’, ‘long grain rice A’ or ‘long grain rice B’).

4.   A period of at least six days must separate the date of entry into force of the Regulation opening the tendering procedure and the scheduled deadline for the first submission of bids.

5.   The call for tender published by the intervention agency shall stipulate in particular the minimum quantities to which bids must refer. These quantities shall be at least 10 tonnes for durum wheat and 20 tonnes for rice.

However, if the conditions and practices of the wholesale trade or environmental regulations in force in a Member State justify the application of minimum quantities larger than those laid down in the first subparagraph above, these quantities shall be laid down in the call for tender by the relevant intervention agency.

6.   The obligations resulting from the tendering procedure shall not be transferable.

Article 4

Conditions for the submission and admissibility of bids

1.   The purchases referred to in Article 3 shall take place on the basis of bids submitted by operators to intervention agencies in the Member States, with bids being submitted in writing or electronically, with acknowledgement of receipt.

2.   In order for a bid to be admissible by the intervention agency, it must include the following:

| (a) | a form supplied by the Member States, based on a harmonised model produced by the Commission and meeting the conditions laid down in Article 24, including, at least, the following information:






  (i) | the name of the bidder; its address and VAT registration number in the Member State in which it performs its main activity, or its farm registry number; |
| --- | --- | --- |

(a)

a form supplied by the Member States, based on a harmonised model produced by the Commission and meeting the conditions laid down in Article 24, including, at least, the following information:

(i)

the name of the bidder; its address and VAT registration number in the Member State in which it performs its main activity, or its farm registry number;

| (ii) | the product offered, indicating, in the case of rice, the type and variety; |
| --- | --- |

(ii)

the product offered, indicating, in the case of rice, the type and variety;

| (iii) | the place where the product is stored at the time that the bid is submitted; |
| --- | --- |

(iii)

the place where the product is stored at the time that the bid is submitted;

| (iv) | the storage facilities at the intervention centre for which the bid is made at the lowest price; |
| --- | --- |

(iv)

the storage facilities at the intervention centre for which the bid is made at the lowest price;

| (v) | the quantity offered, the year in which the product offered was harvested, an indication of its Community origin and the Community area of production; |
| --- | --- |

(v)

the quantity offered, the year in which the product offered was harvested, an indication of its Community origin and the Community area of production;

| (vi) | the price proposed per tonne for merchandise corresponding to the minimum quality for durum wheat or the standard quality for rice, sent to the storage facility at the designated intervention centre, and not unloaded, and expressed in EUR to a maximum of two decimal points. This price shall not exceed the reference price referred to in Article 8(a) of Regulation (EC) No 1234/2007 in respect of durum wheat or the reference price referred to in Article 8(b) of the same Regulation in the case of paddy rice; |
| --- | --- |

(vi)

the price proposed per tonne for merchandise corresponding to the minimum quality for durum wheat or the standard quality for rice, sent to the storage facility at the designated intervention centre, and not unloaded, and expressed in EUR to a maximum of two decimal points. This price shall not exceed the reference price referred to in Article 8(a) of Regulation (EC) No 1234/2007 in respect of durum wheat or the reference price referred to in Article 8(b) of the same Regulation in the case of paddy rice;

| (vii) | for rice, the pesticide treatments carried out after harvest, specifying the doses used; |
| --- | --- |

(vii)

for rice, the pesticide treatments carried out after harvest, specifying the doses used;

| (viii) | the main characteristics of the product offered; |
| --- | --- |

(viii)

the main characteristics of the product offered;

| (b) | the following documents are to be enclosed:






  (i) | evidence that the bidder has lodged a security of EUR 30 per tonne for durum wheat or EUR 50 per tonne for paddy rice, prior to the deadline for submission of bids; this security may be lodged in the Member State where the bidder conducts its main activity if it submits a bid in another Member State; |
| --- | --- | --- |

(b)

the following documents are to be enclosed:

(i)

evidence that the bidder has lodged a security of EUR 30 per tonne for durum wheat or EUR 50 per tonne for paddy rice, prior to the deadline for submission of bids; this security may be lodged in the Member State where the bidder conducts its main activity if it submits a bid in another Member State;

| (ii) | a declaration from the bidder confirming that the quantities offered are situated in the storage facilities referred to in point (a)(iii) of this paragraph; |
| --- | --- |

(ii)

a declaration from the bidder confirming that the quantities offered are situated in the storage facilities referred to in point (a)(iii) of this paragraph;

| (iii) | a declaration from the bidder to the effect that the bid relates to a homogenous batch, and that, with regard to rice, this batch consists of paddy rice of the same variety and that the minimum quantities are those laid down in the call for tender published by the intervention agency. |
| --- | --- |

(iii)

a declaration from the bidder to the effect that the bid relates to a homogenous batch, and that, with regard to rice, this batch consists of paddy rice of the same variety and that the minimum quantities are those laid down in the call for tender published by the intervention agency.

3.   The intervention agency shall register the bids received, the date on which they were received and the quantities concerned.

4.   Bids shall be firm and definitive.

Article 5

Verification of bids by the intervention agency

1.   Intervention agencies shall verify the admissibility of bids on the basis of the requirements specified in Article 4(2).

If the bid is not admissible, the operator concerned shall be notified thereof immediately by the intervention agency.

2.   The compliance of the documents referred to in Article 4(2)(b)(ii) and (iii) may be verified once the admissibility of bids has been established by the intervention agency, if necessary with the assistance of the intervention agency responsible for the storage facility designated by the bidder, in accordance with Article 22(3).

In the event of one or another of the documents referred to in the first subparagraph above not complying, the bid shall be cancelled and Article 9(2) shall apply.

Article 6

Notification of bids to the Commission

1.   By 14.00 (Brussels time) on the day after the deadline for submission of bids at the latest, the intervention agency shall notify the Commission of the admissible bids, subject to the conditions laid down in Article 24. The tenderers shall not be identified.

If no admissible tenders are received, the Member State shall notify the Commission thereof within the same time limit.

2.   Admissible bids which have not been communicated to the Commission shall be excluded from the tender.

Article 7

Decision on the basis of the tenders

On the basis of the bids communicated in accordance with Article 6(1) of this Regulation, the Commission shall decide either not to proceed with bids received or establish the maximum buying-in price, in accordance with the procedure set out in Article 195(2) of Regulation (EC) No 1234/2007.

Article 8

Decisions on tenders

1.   Once a maximum buying-in price has been established by the Commission, in accordance with Article 7, the intervention agencies shall accept admissible bids equal to or below the maximum amount. All other bids shall be rejected.

2.   If no maximum buying-in price has been established, all bids shall be rejected.

3.   Intervention agencies, either following publication of the regulation or notification of the decision establishing the maximum buying-in price referred to in Article 7, or specifying that bids have not been successful, shall take the decisions referred to in paragraphs 1 and 2.

4.   Each tenderer shall be informed by the relevant agency of the result of the tender bid by no later than the working day following the publication or notification referred to in paragraph 3.

Article 9

Release and forfeit of securities

1.   The actual presence of products in the storage facility designated by the bidder in accordance with Article 4(2)(a)(iii), the presentation of a homogeneous batch, the continuation of the bid communicated to the Commission and the take-over of the product by the relevant agency shall be the main requirements within the meaning of Article 20(2) of Commission Regulation (EEC) No 2220/85 (8).

2.   If the main requirements referred to in paragraph 1 above are not complied with, the security shall be forfeit save in cases of force majeure, and shall be entered as assigned revenue in accordance with Article 12 of Commission Regulation (EC) No 883/2006 (9).

3.   For the purposes of applying this Article, intervention agencies shall carry out checks on the quantities present in the places of storage by applying mutatis mutandis the rules and conditions laid down in Regulation (EC) No 884/2006 as regards checks on the physical presence of products stored under public storage operations, and more specifically those provided for under point B.III of Annex I to that Regulation. These checks shall be carried out on at least 5 % of the bids and 5 % of the quantities offered, on the basis of a risk analysis.

4.   The security shall be released from the time that the decision referred to in Article 8(3) is published, if the bid is rejected.

5.   With regard to bids selected, the security shall be released within five working days following the date on which the take-over record referred to in the third subparagraph of Article 18(1) is drawn up.

SECTION 3

PROCEDURE FOR THE TRANSIT OF PRODUCTS

Article 10

Delivery

1.   The date or dates for delivery to the storage centre at the approved intervention centre designated by the bidder shall be established by the intervention agency and notified to the bidder as soon as possible.

However, if products cannot be delivered to the storage facility at the intervention centre designated by the bidder, the intervention agency shall designate storage facilities at another approved intervention centre, or storage facilities at another intervention centre, to which delivery must place, at the lowest cost, and shall set the delivery date or dates.

2.   All products shall be delivered to the storage centre at the approved intervention centre by no later than the end of the third month following the month in which the bid was received, and no later than 30 June for durum wheat or 31 August for paddy rice.

3.   The representative of the intervention agency shall take the goods over in the presence of the bidder or his duly authorised agent.

4.   The quantity delivered must be weighed in the presence of the bidder or his duly authorised agent and a representative of the intervention agency who must be independent vis-à-vis the bidder.

However, the representative of the intervention agency may also be the storekeeper. In that case:

| (a) | within 30 days of take-over, the intervention agency shall itself conduct an inspection involving at least a volumetric check; any difference between the quantity determined by weighing and the quantity estimated in accordance with the volumetric method must not exceed 5 %; |
| --- | --- |

(a)

within 30 days of take-over, the intervention agency shall itself conduct an inspection involving at least a volumetric check; any difference between the quantity determined by weighing and the quantity estimated in accordance with the volumetric method must not exceed 5 %;

| (b) | where the tolerance is not exceeded, the storekeeper shall bear all costs relating to any quantities missing, at a later weight check, compared to the weight entered in the accounts on take-over; |
| --- | --- |

(b)

where the tolerance is not exceeded, the storekeeper shall bear all costs relating to any quantities missing, at a later weight check, compared to the weight entered in the accounts on take-over;

| (c) | where the tolerance is exceeded, weighing shall take place forthwith. The cost of weighing shall be borne by the storekeeper if the weight determined is less than that recorded, or by the Member State if it is more. |
| --- | --- |

(c)

where the tolerance is exceeded, weighing shall take place forthwith. The cost of weighing shall be borne by the storekeeper if the weight determined is less than that recorded, or by the Member State if it is more.

Article 11

Transport costs

1.   The cost of transporting merchandise to the storage facility at the intervention centre designated by the bidder as cheaply as possible, in accordance with Article 4(2)(a)(iv), shall be met by the bidder, where the distance involved is equal to or less than 100 km. Transport costs over 100 km shall be borne by the intervention agency.

2.   If the storage facility at the intervention centre designated by the bidder is changed by the intervention agency in accordance with the second subparagraph of Article 10(1), the additional transport costs (except for the first 20 km) shall be met by the intervention agency. However, transport costs over 100 km shall be borne by the intervention agency in their entirety.

3.   The costs to be met by the intervention agency, referred to in paragraphs 1 and 2 above shall be reimbursed by the Commission, on a non-flat rate basis, in accordance with Article 4(1)(c) of Regulation (EC) No 884/2006.

CHAPTER II

SPECIFIC PROVISIONS FOR DURUM WHEAT

Article 12

Quality of durum wheat offered

1.   In order to be accepted for intervention, the durum wheat must be of sound and fair merchantable quality.

2.   Durum wheat must be considered unimpaired in order to be deemed of sound and fair merchantable quality. To this end, it must meet the quality criteria examined according to the characteristics set out in Annex I, Part A and the minimum quality criteria for durum wheat set out in Annex I, Part B.

Article 13

Sampling and tests of offers of durum wheat

1.   The quality characteristics shall be established on the basis of a representative sample of each batch of durum wheat offered, consisting of samples taken at the rate of once every delivery for at least every 60 tonnes.

2.   The intervention agency shall see that the characteristics of the samples taken are analysed under its responsibility within 20 working days of the representative sample being made up.

3.   The standard methods to be used to determine the quality of durum wheat offered for intervention are set out in Annex II as follows:

| — | Part A: Standard method for determining matter other than basic cereals of unimpaired quality, |
| --- | --- |

—

Part A: Standard method for determining matter other than basic cereals of unimpaired quality,

| — | Part B: Standard method for determining the moisture content of durum wheat, |
| --- | --- |

—

Part B: Standard method for determining the moisture content of durum wheat,

| — | Part C: Standard method for determining the rate of loss of vitreous aspect of durum wheat, |
| --- | --- |

—

Part C: Standard method for determining the rate of loss of vitreous aspect of durum wheat,

| — | Part D: Other methods applicable to determining the quality of durum wheat. |
| --- | --- |

—

Part D: Other methods applicable to determining the quality of durum wheat.

4.   Member States shall check levels of contaminants, including radioactivity, on the basis of a risk analysis, taking account in particular of the information supplied by the bidder and the commitments of the latter regarding compliance with the standards set, especially in the light of the results of the analyses. If necessary, the rate and scope of the controls shall be determined in accordance with the procedure referred to in Article 195(2) of Regulation (EC) No 1234/2007, particularly where the market situation may be seriously disrupted by contaminants.

5.   The bidder shall bear the costs relating to:

| (a) | analyses of contaminants; |
| --- | --- |

(a)

analyses of contaminants;

| (b) | the amylasic activity (Hagberg) test; |
| --- | --- |

(b)

the amylasic activity (Hagberg) test;

| (c) | the determination of the protein content; |
| --- | --- |

(c)

the determination of the protein content;

| (d) | the withdrawal of the products if the tests have shown that the durum wheat offered does not meet the minimum quality required for intervention. |
| --- | --- |

(d)

the withdrawal of the products if the tests have shown that the durum wheat offered does not meet the minimum quality required for intervention.

6.   The test results shall be notified to the bidder in the take-over record provided for in Article 18.

7.   In cases of dispute, the intervention agency shall have the necessary tests on the products in question carried out again, the cost being met by the losing party.

8.   In the event that tests or inspections do not allow the durum wheat offered to be accepted for intervention, the bidder may replace the batch concerned, no later than 20 working days afterwards, without prejudice to the deadline for delivery set out in Article 10(2). By way of derogation from Article 11, the transport costs involved in this replacement shall be borne solely by the bidder.

Article 14

Take-over of offers of durum wheat

1.   The durum wheat offered shall be taken over by the intervention agency when the quantity and compliance with the conditions, as set out in Article 12, have been established by its representative for the entire batch in respect of the goods delivered to the intervention store, in accordance with the provisions of Article 13.

2.   The take-over must take place within 60 days of the last delivery as set out in Article 10(2), but no later than 31 July.

However, if the provisions of Article 13(8) apply, the take-over must take place no later than 31 August.

CHAPTER III

SPECIFIC PROVISIONS FOR RICE

Article 15

Quality of paddy rice offered

1.   In order to be accepted for intervention, the paddy rice must be of sound and fair merchantable quality.

2.   Paddy rice shall be considered of sound and fair merchantable quality if:

| (a) | it meets the criteria set out in Annex III, Part A, with regard to the base milling yield of the rice, and in Annex III, Part B, with regard to the maximum percentage of defects permissible; |
| --- | --- |

(a)

it meets the criteria set out in Annex III, Part A, with regard to the base milling yield of the rice, and in Annex III, Part B, with regard to the maximum percentage of defects permissible;

| (b) | its moisture content does not exceed 14,5 %; |
| --- | --- |

(b)

its moisture content does not exceed 14,5 %;

| (c) | it is free of odour and does not contain live insects; |
| --- | --- |

(c)

it is free of odour and does not contain live insects;

| (d) | the level of radioactivity does not exceed the maximum levels permitted by Community legislation. |
| --- | --- |

(d)

the level of radioactivity does not exceed the maximum levels permitted by Community legislation.

Article 16

Sampling and tests of offers of paddy rice

1.   With a view to verifying the requisite quality requirements under Article 15 for accepting the rice for intervention, samples shall be taken by the intervention agency in the presence of the bidder or his/her duly authorised representative.

Three representative samples, each weighing a minimum of one kilogram, shall be collected. One each shall go to:

| (a) | the bidder; |
| --- | --- |

(a)

the bidder;

| (b) | the store where the take-over is to take place; |
| --- | --- |

(b)

the store where the take-over is to take place;

| (c) | the intervention agency. |
| --- | --- |

(c)

the intervention agency.

To make up the representative samples, the number of samples to be taken shall be obtained by dividing the quantity of the batch on offer by 10 tonnes. Each sample shall weigh the same. The representative samples shall be made up of the sum of the individual samples, divided by three.

The requisite quality requirements shall be verified using the representative sample intended for the store where take-over is to take place.

2.   Representative samples shall be made up for each part-delivery (lorry, barge, railway wagon), under the conditions set out in paragraph 1.

Before its entry into the intervention store the examination of each part-delivery may be restricted to a check of the moisture content and impurity level and verification that no live insects are present. However, if it later becomes apparent when the check is finalised that a part-delivery does not satisfy the minimum quality requirements, the batch shall be refused for take-over. The entire batch must be withdrawn. The bidder shall bear the costs of this operation.

If the intervention agency in a Member State is able to check all the minimum quality requirements for each part-delivery before it enters the store, it shall refuse take-over of any part-delivery that fails to satisfy these requirements.

3.   The rice shall be monitored for radioactive contamination only if the situation so requires and during the necessary period. Where necessary, the duration and scope of checks shall be determined in accordance with the procedure referred to in Article 195(2) of Regulation (EC) No 1234/2007.

4.   The test results shall be notified to the bidder in the take-over record provided for in Article 18.

5.   In cases of dispute, the intervention agency shall have the necessary tests on the products in question carried out again, the cost being met by the losing party.

The new test shall be carried out by a laboratory approved by the intervention agency on the basis of a new representative sample composed of equal parts of representative samples kept by the bidder and the intervention agency. In the event of part-deliveries of the batch offered, the result shall be obtained from the weighted average of the findings of the analyses of the new representative samples of each part-delivery.

6.   In the event where the tests do not allow the paddy rice offered to be accepted for intervention, the bidder may replace the batch concerned, no later than 20 working days afterwards, without prejudice to the deadline for delivery set out in Article 10(2). By way of derogation from Article 11, the transport costs inherent in this replacement shall be borne solely by the bidder.

Article 17

Take-over of offers of paddy rice

1.   The rice offered shall be taken over by the intervention agency where the minimum quantity and characteristics laid down in Articles 3 and 15 have been established by its agent for the goods delivered to the intervention store, in accordance with the provisions of Article 16.

2.   The take-over must take place within 60 days of the last delivery as set out in Article 10(2), but no later than 30 September.

However, if the provisions of Article 16(6) apply, the take-over must take place no later than 31 October.

CHAPTER IV

COMMON PROVISIONS FOR TAKE-OVER, INSPECTIONS AND COMMUNICATIONS

Article 18

Take-over record

1.   A take-over record shall be drawn up for each offer, by the intervention agency responsible for the approval of the storage premises for which the lowest bid was submitted. The bidder or his/her representative may be present when the record is being drawn up.

It shall indicate at least:

| (a) | the number of samples taken to make up the representative sample; |
| --- | --- |

(a)

the number of samples taken to make up the representative sample;

| (b) | the date(s) on which the quantity and characteristics of the batch were checked; |
| --- | --- |

(b)

the date(s) on which the quantity and characteristics of the batch were checked;

| (c) | the weight delivered and the variety of the rice; |
| --- | --- |

(c)

the weight delivered and the variety of the rice;

| (d) | the characteristics of the batch as indicated by the tests; |
| --- | --- |

(d)

the characteristics of the batch as indicated by the tests;

| (e) | the body responsible for the tests. |
| --- | --- |

(e)

the body responsible for the tests.

This record is signed and dated by the intervention agency and the storekeeper.

2.   The take-over record may be drawn up once 95 % of the quantity offered is taken over.

Article 19

Establishing the price to be paid to the bidder and payment

1.   The price payable to the bidder shall be the bid price referred to in Article 4(2)(a)(vi) of this Regulation, without prejudice to the provisions of Article 11 and any price increases or reductions referred to in Annex IV, for durum wheat and in Annex V, for paddy rice, or set in accordance with Article 18(4)(b) of Regulation (EC) No 1234/2007.

2.   Payment shall be made no later than 35 days following the date of take-over, as set out in Articles 14 and 17, where applicable.

Where Article 13(7) applies with regard to durum wheat, or where Article 16(5) applies with regard to paddy rice, payment shall be made as soon as possible after the results of the last test are notified to the bidder.

Where bidders must submit an invoice before they can be paid and where this invoice is not submitted within the time limit laid down in the first subparagraph, payment shall be made within five working days of the actual submission of the invoice.

Article 20

Control measures

1.   Without prejudice to the checks required by this Regulation for the take-over of goods, the checks of the intervention stocks shall be carried out under the conditions set out in Article 2 of Regulation (EC) No 884/2006.

2.   Where the checks are to be carried out on the basis of the risk analysis referred to in Article 13(4) of this Regulation, the Member State shall be liable for the financial consequences of any failure to comply with the maximum admissible contaminant level in accordance with the rules set out in Article 2 of Regulation (EC) No 884/2006.

However, in the case of ochratoxin A and aflatoxin, if the Member State concerned is able to prove to the Commission’s satisfaction that the standards were met on entry, that normal storage conditions were observed and that the storekeeper’s other commitments were respected, the financial liability shall be borne by the Community budget.

3.   Where the storage premises designated in accordance with Article 4(2)(a)(iii) is in a Member State other than that where the offer is made, and the intervention agency that received the offer decides to make an on-site check to verify the actual presence of the products, this agency shall send a request for a check and a copy of the offer to the intervention agency responsible for those storage premises. The on-site check shall be carried out within the period set by the intervention agency that received the offer.

Article 21

National rules

The intervention agencies shall, where necessary, adopt additional procedures and conditions for take-overs, compatible with the provisions of this Regulation, to take account of any special conditions existing in the Member State in question.

Article 22

Communication of the take-overs to the Commission and the intervention agencies

1.   Subject to the conditions set out in Article 24, by no later than 14.00 (Brussels time) each Wednesday, each Member State must communicate the following for the previous week by product and by type of product, where applicable:

| (a) | the total quantities corresponding to the bids accepted pursuant to Article 8; |
| --- | --- |

(a)

the total quantities corresponding to the bids accepted pursuant to Article 8;

| (b) | the total quantities corresponding to the bids cancelled pursuant to the second subparagraph of Article 5(2); |
| --- | --- |

(b)

the total quantities corresponding to the bids cancelled pursuant to the second subparagraph of Article 5(2);

| (c) | the total quantities accepted but not delivered within the deadlines set out in Article 10; |
| --- | --- |

(c)

the total quantities accepted but not delivered within the deadlines set out in Article 10;

| (d) | the total quantities not meeting the minimum characteristics required for take-over; |
| --- | --- |

(d)

the total quantities not meeting the minimum characteristics required for take-over;

| (e) | the total quantities taken over. |
| --- | --- |

(e)

the total quantities taken over.

2.   Each Member State must, under the conditions set out in Article 24, by the end of the month following the takeover deadline referred to in Article 14(2) of this Regulation, by region set out in Annex III to Council Regulation (EEC) No 837/90 concerning statistical information to be supplied by the Member States on cereals production (10), communicate the average results of specific weight, moisture content, percentage of broken grains and protein content recorded for the batches of durum wheat taken over.

3.   The exchange of information between the intervention agencies, with regard to the checks provided for in Article 20(3), shall be electronic, under the conditions set out in Article 24.

Article 23

Communication from the intervention agencies and approved intervention centres to the Commission

1.   Member States shall communicate to the Commission, under the conditions set out in Article 24, the following information:

| (a) | on the intervention agencies approved in accordance with Article 1; and |
| --- | --- |

(a)

on the intervention agencies approved in accordance with Article 1; and

| (b) | on the intervention centres approved in accordance with Article 2, and their storage premises. |
| --- | --- |

(b)

on the intervention centres approved in accordance with Article 2, and their storage premises.

2.   The Commission shall publish the list of the intervention agencies provided for in Article 1(2) in the ‘C’ series of the Official Journal of the European Union.

3.   Amendments to the list of intervention centres and their storage premises, provided for in Article 2(3), and to the list of intervention agencies, provided for in Article 23(2), shall be made available to the Member States and to the public by all appropriate technical means via the information systems put in place by the Commission, including publication on the Internet.

Article 24

Method applicable to communication

1.   The communications and exchanges of information between the Member States and the Commission provided for by this Regulation shall be electronic via the information systems made available to the competent authorities by the Commission or the Member States.

2.   The documents concerned shall be drawn up and sent in line with the procedures set by these information systems.

3.   The form and content of the documents shall be defined on the basis of models or methods made available to users through information systems. Those models and methods shall be adapted and updated after the Management Committee for the Common Organisation of Agricultural Markets has been informed.

4.   Data on communications shall be entered and updated in the information systems under the responsibility of the competent authority of the Member State, in accordance with the access rights granted by the authorities in question.

CHAPTER V

AMENDMENTS, REPEALS AND FINAL PROVISIONS

Article 25

Amendment of Regulation (EC) No 428/2008

In Annex I to Regulation (EC) No 428/2008, column (4) on durum wheat is deleted.

Article 26

Amendment of Regulation (EC) No 687/2008

Regulation (EC) No 687/2008 is amended as follows:

| 1. | in Article 1, the first subparagraph is replaced by the following:
  ‘During the periods referred to in the first subparagraph of Article 11(1) of Regulation (EC) No 1234/2007, any holder of a homogeneous batch of not less than 80 tonnes of common wheat, barley, maize or sorghum, harvested within the Community, shall be entitled to offer these cereals to the paying agency or intervention agency (hereinafter both referred to as the ‘intervention agency’).’; |
| --- | --- |

1.

in Article 1, the first subparagraph is replaced by the following:

‘During the periods referred to in the first subparagraph of Article 11(1) of Regulation (EC) No 1234/2007, any holder of a homogeneous batch of not less than 80 tonnes of common wheat, barley, maize or sorghum, harvested within the Community, shall be entitled to offer these cereals to the paying agency or intervention agency (hereinafter both referred to as the ‘intervention agency’).’;

| 2. | in the first subparagraph of Article 4(2), point (a) is replaced by the following:






  ‘(a) | for common wheat, those established under Regulation (EEC) No 315/93, including the requirements regarding the Fusarium-toxin level for common wheat laid down in points 2.4 to 2.7 of the Annex to Commission Regulation (EC) No 1881/2006 (11); |
| --- | --- | --- |

2.

in the first subparagraph of Article 4(2), point (a) is replaced by the following:

‘(a)

for common wheat, those established under Regulation (EEC) No 315/93, including the requirements regarding the Fusarium-toxin level for common wheat laid down in points 2.4 to 2.7 of the Annex to Commission Regulation (EC) No 1881/2006 (11);

| 3. | Article 5(h) is deleted; |
| --- | --- |

3.

Article 5(h) is deleted;

| 4. | Article 7(2)(c) is replaced by the following:






  ‘(c) | determination of the protein content of common wheat;’; |
| --- | --- | --- |

4.

Article 7(2)(c) is replaced by the following:

‘(c)

determination of the protein content of common wheat;’;

| 5. | Article 10 is amended as follows:






  (a) | points (c) and (d) are replaced by the following:






  ‘(c) | where the percentage of broken grains exceeds 3 % for common wheat and barley, and 4 % for maize and sorghum, a reduction of EUR 0,05 shall be applied for each additional 0,1 percentage point; |
| --- | --- | --- | --- |

5.

Article 10 is amended as follows:

(a)

points (c) and (d) are replaced by the following:

‘(c)

where the percentage of broken grains exceeds 3 % for common wheat and barley, and 4 % for maize and sorghum, a reduction of EUR 0,05 shall be applied for each additional 0,1 percentage point;

| (d) | where the percentage of grain impurities exceeds 4 % for maize and sorghum, and 5 % for common wheat and barley, a reduction of EUR 0,05 shall be applied for each additional 0,1 percentage point;’; |
| --- | --- |

(d)

where the percentage of grain impurities exceeds 4 % for maize and sorghum, and 5 % for common wheat and barley, a reduction of EUR 0,05 shall be applied for each additional 0,1 percentage point;’;

| (b) | point (f) is replaced by the following:






  ‘(f) | where the percentage of miscellaneous impurities (Schwarzbesatz) exceeds 1 % for common wheat, barley, maize and sorghum, a reduction of EUR 0,1 shall be applied for each additional 0,1 percentage point;’; |
| --- | --- | --- |

(b)

point (f) is replaced by the following:

‘(f)

where the percentage of miscellaneous impurities (Schwarzbesatz) exceeds 1 % for common wheat, barley, maize and sorghum, a reduction of EUR 0,1 shall be applied for each additional 0,1 percentage point;’;

| (c) | point (g) is deleted; |
| --- | --- |

(c)

point (g) is deleted;

| 6. | in Annex I, the ‘Durum wheat’ column is deleted; |
| --- | --- |

6.

in Annex I, the ‘Durum wheat’ column is deleted;

| 7. | Annex II is amended as follows:






  (a) | point 1.2 is amended as follows:






  (i) | the first subparagraph of point (a) is replaced by the following:
  ‘Grains which, after elimination from the sample of all other matter referred to in this Annex, pass through sieves with apertures of the following dimensions, shall be considered as shrivelled grains: common wheat 2,0 mm, barley 2,2 mm.’; |
| --- | --- | --- | --- |

7.

Annex II is amended as follows:

(a)

point 1.2 is amended as follows:

(i)

the first subparagraph of point (a) is replaced by the following:

‘Grains which, after elimination from the sample of all other matter referred to in this Annex, pass through sieves with apertures of the following dimensions, shall be considered as shrivelled grains: common wheat 2,0 mm, barley 2,2 mm.’;

| (ii) | in point (d), the second subparagraph is deleted; |
| --- | --- |

(ii)

in point (d), the second subparagraph is deleted;

| (b) | point 1.3 is replaced by the following:
  ‘1.3.   Sprouted grains

  Sprouted grains are those in which the radicle or plumule is clearly visible to the naked eye. However, account must be taken of the general appearance of the sample when its content of sprouted grains is assessed. In some kinds of cereals the germ is protuberant and the germ tegument splits when the batch of cereals is shaken. These grains resemble sprouted grains but must not be included in that group. Sprouted grains are only those where the germ has undergone clearly visible changes which make it easy to distinguish the sprouted grain from the normal grain.’; |
| --- | --- |

(b)

point 1.3 is replaced by the following:

‘1.3.   Sprouted grains

Sprouted grains are those in which the radicle or plumule is clearly visible to the naked eye. However, account must be taken of the general appearance of the sample when its content of sprouted grains is assessed. In some kinds of cereals the germ is protuberant and the germ tegument splits when the batch of cereals is shaken. These grains resemble sprouted grains but must not be included in that group. Sprouted grains are only those where the germ has undergone clearly visible changes which make it easy to distinguish the sprouted grain from the normal grain.’;

| (c) | point 2.1 is deleted; |
| --- | --- |

(c)

point 2.1 is deleted;

| 8. | point 1 of Annex III is amended as follows:






  (a) | the first subparagraph is replaced by the following:
  ‘For common wheat and barley, an average sample of 250 g shall be passed through two sieves, one with slotted perforations of 3,5 mm and the other with slotted perforations of 1,0 mm, for half a minute each.’; |
| --- | --- | --- |

8.

point 1 of Annex III is amended as follows:

(a)

the first subparagraph is replaced by the following:

‘For common wheat and barley, an average sample of 250 g shall be passed through two sieves, one with slotted perforations of 3,5 mm and the other with slotted perforations of 1,0 mm, for half a minute each.’;

| (b) | the seventh subparagraph is replaced by the following:
  ‘The partial sample shall be passed for half a minute through a sieve with a mesh size of 2,0 mm for common wheat and 2,2 mm for barley. Matter which passes through this sieve shall be considered as shrivelled grains. Grains damaged by frost and unripe green grains belong to the ‘shrivelled grains’ group.’; |
| --- | --- |

(b)

the seventh subparagraph is replaced by the following:

‘The partial sample shall be passed for half a minute through a sieve with a mesh size of 2,0 mm for common wheat and 2,2 mm for barley. Matter which passes through this sieve shall be considered as shrivelled grains. Grains damaged by frost and unripe green grains belong to the ‘shrivelled grains’ group.’;

| 9. | Annex VI is deleted. |
| --- | --- |

9.

Annex VI is deleted.

Article 27

Repeal

Regulation (EC) No 489/2005 is repealed with effect from 1 September 2009.

References made to the repealed Regulation shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VI.

Article 28

Entry into force and application

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 1 July 2009 for durum wheat and from 1 September 2009 for the rice sector.

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

Done at Brussels, 24 July 2009.

For the Commission

Mariann FISCHER BOEL

Member of the Commission

---

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

1

(2)  OJ L 30, 31.1.2009, p. 1.

2

(3)  OJ L 171, 23.6.2006, p. 35.

3

(4)  OJ L 37, 13.2.1993, p. 1.

4

(5)  OJ L 81, 30.3.2005, p. 26.

5

(6)  OJ L 129, 17.5.2008, p. 8.

6

(7)  OJ L 192, 19.7.2008, p. 20.

7

(8)  OJ L 205, 3.8.1985, p. 5.

8

(9)  OJ L 171, 23.6.2006, p. 1.

9

(10)  OJ L 88, 3.4.1990, p. 1.

10

(11)  OJ L 364, 20.12.2006, p. 5.’

11

---

ANNEX I

(Article 12(2))

PART A

1.   DEFINITION OF CHARACTERISTICS TO BE EXAMINED IN ORDER TO QUALIFY A BASIC CEREAL AS BEING OF UNIMPAIRED QUALITY

1.1.   Broken grains

All grains whose endosperm is partially uncovered shall be regarded as broken grains. Grains damaged by threshing and grains from which the germ has been removed also belong to this group.

1.2.   Grain impurities

| (a) | Shrivelled grains:

  Grains which, after elimination from the sample of all other matter referred to in this Annex, pass through sieves with apertures of the following dimensions, shall be considered as shrivelled grains: durum wheat: 1,9 mm.
  ‘shrivelled grains’ means grains which, after elimination of all other matter referred to in this Annex, pass through sieves with apertures of 2,0 mm.
  In addition, grains damaged by frost and unripe grains (green) belong to this group; |
| --- | --- |

(a)

Shrivelled grains:

Grains which, after elimination from the sample of all other matter referred to in this Annex, pass through sieves with apertures of the following dimensions, shall be considered as shrivelled grains: durum wheat: 1,9 mm.

‘shrivelled grains’ means grains which, after elimination of all other matter referred to in this Annex, pass through sieves with apertures of 2,0 mm.

In addition, grains damaged by frost and unripe grains (green) belong to this group;

| (b) | Other cereals:

  All grains which do not belong to the species of grain sampled; |
| --- | --- |

(b)

Other cereals:

All grains which do not belong to the species of grain sampled;

| (c) | Grains damaged by pests:

  Grains which have been nibbled. Bug-ridden grains also belong to this group; |
| --- | --- |

(c)

Grains damaged by pests:

Grains which have been nibbled. Bug-ridden grains also belong to this group;

| (d) | Grains in which the germ is discoloured, mottled grains, grains affected with fusariosis:

  Grains in which the germ is discoloured are those of which the tegument is coloured brown to brownish black and of which the germ is normal and not sprouting.
  For durum wheat:






  — | grains which show a brown to brownish black discoloration elsewhere than on the germ itself shall be considered as mottled grains, |
| --- | --- | --- |

(d)

Grains in which the germ is discoloured, mottled grains, grains affected with fusariosis:

Grains in which the germ is discoloured are those of which the tegument is coloured brown to brownish black and of which the germ is normal and not sprouting.

For durum wheat:

—

grains which show a brown to brownish black discoloration elsewhere than on the germ itself shall be considered as mottled grains,

| — | grains affected with fusariosis are grains whose pericarp is contaminated with Fusarium mycelium; such grains look slightly shrivelled, wrinkled and have pink or white diffuse patches with an ill-defined outline; |
| --- | --- |

—

grains affected with fusariosis are grains whose pericarp is contaminated with Fusarium mycelium; such grains look slightly shrivelled, wrinkled and have pink or white diffuse patches with an ill-defined outline;

| (e) | Grains overheated during drying are those which show external signs of scorching but which are not damaged grains. |
| --- | --- |

(e)

Grains overheated during drying are those which show external signs of scorching but which are not damaged grains.

1.3.   Sprouted grains

Sprouted grains are those in which the radicle or plumule is clearly visible to the naked eye. However, account must be taken of the general appearance of the sample when its content of sprouted grains is assessed. In some kinds of cereals the germ is protuberant, e.g. in durum wheat, and the germ tegument splits when the batch of cereals is shaken. These grains resemble sprouted grains but must not be included in that group. Sprouted grains are only those where the germ has undergone clearly visible changes which make it easy to distinguish the sprouted grain from the normal grain.

1.4.   Miscellaneous impurities (Schwarzbesatz)

Grains of basic cereals and other cereals which are damaged, affected by ergot or decayed are to be classified as ‘miscellaneous impurities’ even if they have defects which belong to other categories.

| (a) | Extraneous seeds:

  Extraneous seeds are seeds of plants, whether or not cultivated, other than cereals. They include seeds not worth recovering, seeds which can be used for livestock and noxious seeds.
  ‘Noxious seeds’ means seeds which are toxic to humans and animals, seeds hampering or complicating the cleaning and milling of cereals and seeds affecting the quality of products processed from cereals; |
| --- | --- |

(a)

Extraneous seeds:

Extraneous seeds are seeds of plants, whether or not cultivated, other than cereals. They include seeds not worth recovering, seeds which can be used for livestock and noxious seeds.

‘Noxious seeds’ means seeds which are toxic to humans and animals, seeds hampering or complicating the cleaning and milling of cereals and seeds affecting the quality of products processed from cereals;

| (b) | Damaged grains:

  Damaged grains are those rendered unfit for human consumption and, as regards feed grain, for consumption by cattle, owing to putrefaction, mildew, or bacterial or other causes.
  Damaged grains also include grains damaged by spontaneous heat generation or too extreme heating during drying. These ‘heated’ or ‘smutty’ grains are fully grown grains in which the tegument is coloured greyish brown to black, while the cross-section of the kernel is coloured yellowish grey to brownish black.
  Grains attacked by wheat-midge shall be considered damaged grains only when more than half the surface of the grain is coloured grey to black as a result of secondary cryptogamic attack. Where discoloration covers less then half the surface of the grain, they must be classed with grains damaged by pests; |
| --- | --- |

(b)

Damaged grains:

Damaged grains are those rendered unfit for human consumption and, as regards feed grain, for consumption by cattle, owing to putrefaction, mildew, or bacterial or other causes.

Damaged grains also include grains damaged by spontaneous heat generation or too extreme heating during drying. These ‘heated’ or ‘smutty’ grains are fully grown grains in which the tegument is coloured greyish brown to black, while the cross-section of the kernel is coloured yellowish grey to brownish black.

Grains attacked by wheat-midge shall be considered damaged grains only when more than half the surface of the grain is coloured grey to black as a result of secondary cryptogamic attack. Where discoloration covers less then half the surface of the grain, they must be classed with grains damaged by pests;

| (c) | Extraneous matter:

  All matter in a sample of cereals retained by a sieve with apertures of 3,5 mm (with the exception of grains of other cereals and particularly large grains of the basic cereal) and that passing through a sieve with apertures of 1,0 mm shall be considered extraneous matter. Also included are stones, sand, fragments of straw and other impurities in the samples which pass through a sieve with apertures of 3,5 mm and are retained by a sieve with apertures of 1,0 mm; |
| --- | --- |

(c)

Extraneous matter:

All matter in a sample of cereals retained by a sieve with apertures of 3,5 mm (with the exception of grains of other cereals and particularly large grains of the basic cereal) and that passing through a sieve with apertures of 1,0 mm shall be considered extraneous matter. Also included are stones, sand, fragments of straw and other impurities in the samples which pass through a sieve with apertures of 3,5 mm and are retained by a sieve with apertures of 1,0 mm;

| (d) | husks; |
| --- | --- |

(d)

husks;

| (e) | ergot; |
| --- | --- |

(e)

ergot;

| (f) | decayed grains; |
| --- | --- |

(f)

decayed grains;

| (g) | dead insects and fragments of insects. |
| --- | --- |

(g)

dead insects and fragments of insects.

1.5.   Live pests

1.6.   Piebald grains

Piebald grains of durum wheat are grains whose kernel cannot be regarded as entirely vitreous.

1.7.   Colour of cereal

The colour of the cereal is specific to this cereal, free from odour and live pests (including mites) at all stages of its development.

1.8.   Contaminants

The maximum permissible levels of contaminants, including radioactivity, applicable under Community rules shall not exceed the levels established under Regulation (EEC) No 315/93, including the requirements set out in the Annex to Commission Regulation (EC) No 1881/2006 (1).

2.   FACTORS TO TAKE INTO ACCOUNT WHEN DEFINING DURUM WHEAT IMPURITIES

‘Grain impurities’ means shrivelled grains, grains of other cereals, grains damaged by pests, grains in which the germ is discoloured, mottled grains or grains affected with fusariosis and grains overheated during drying.

Miscellaneous impurities means extraneous seeds, damaged grains, extraneous matter, husks, ergot, decayed grains, dead insects and fragments of insects.

PART B

CRITERIA FOR MINIMUM QUALITY OF DURUM WHEAT

| A. | Maximum moisture content |
| --- | --- |

A.

Maximum moisture content

14,5 %

| B. | Maximum percentage of matter which is not basic cereal of unimpaired quality, of which a maximum: |
| --- | --- |

B.

Maximum percentage of matter which is not basic cereal of unimpaired quality, of which a maximum:

12 %

| 1. | Broken grains |
| --- | --- |

1.

Broken grains

6 %

| 2. | Impurities consisting of grains (other than indicated at 3) |
| --- | --- |

2.

Impurities consisting of grains (other than indicated at 3)

5 %

of which:

| (a) | shrivelled grains |
| --- | --- |

(a)

shrivelled grains

| (b) | other cereals |
| --- | --- |

(b)

other cereals

3 %

| (c) | grains damaged by pests |
| --- | --- |

(c)

grains damaged by pests

| (d) | grains in which the germ is discoloured |
| --- | --- |

(d)

grains in which the germ is discoloured

| (e) | grains overheated during drying |
| --- | --- |

(e)

grains overheated during drying

0,50 %

| 3. | Mottled grains and/or grains affected with fusariosis, |
| --- | --- |

3.

Mottled grains and/or grains affected with fusariosis,

5 %

of which:

— grains affected with fusariosis

1,5 %

| 4. | Sprouted grains |
| --- | --- |

4.

Sprouted grains

4 %

| 5. | Miscellaneous impurities (Schwarzbesatz), |
| --- | --- |

5.

Miscellaneous impurities (Schwarzbesatz),

3 %

of which:

| (a) | extraneous seeds: |
| --- | --- |

(a)

extraneous seeds:

— noxious

0,10 %

— other

| (b) | damaged grains |
| --- | --- |

(b)

damaged grains

— grains damaged by spontaneous heating or too extreme heating during drying

0,05 %

— other

| (c) | extraneous matter |
| --- | --- |

(c)

extraneous matter

| (d) | husks |
| --- | --- |

(d)

husks

| (e) | ergot |
| --- | --- |

(e)

ergot

0,05 %

| (f) | decayed grains |
| --- | --- |

(f)

decayed grains

| (g) | dead insects and fragments of insects |
| --- | --- |

(g)

dead insects and fragments of insects

| C. | Maximum percentage of wholly or partially piebald grains |
| --- | --- |

C.

Maximum percentage of wholly or partially piebald grains

27 %

| D. | Maximum tannin content (2) |
| --- | --- |

D.

Maximum tannin content (2)

—

| E. | Minimum specific weight (kg/hl) |
| --- | --- |

E.

Minimum specific weight (kg/hl)

78

| F. | Minimum protein content (2): |
| --- | --- |

F.

Minimum protein content (2):

11,5 %

| G. | Hagberg falling number (seconds) |
| --- | --- |

G.

Hagberg falling number (seconds)

220

| H. | Minimum Zeleny index (ml) — |
| --- | --- |

H.

Minimum Zeleny index (ml) —

—

| — | : | Not applicable |
| --- | --- | --- |

—

:

Not applicable

---

(1)  OJ L 364, 20.12.2006, p. 5.

(2)  As % of dry matter.

---

ANNEX II

(Article 13(3))

PART A

1.   STANDARD METHOD FOR DETERMINING MATTER OTHER THAN BASIC CEREALS OF UNIMPAIRED QUALITY

The standard method for determining matter other than basic cereals of unimpaired quality shall be that set out below:

1.1.   For common wheat, an average sample of 250 g shall be passed through two sieves, one with slotted perforations of 3,5 mm and the other with slotted perforations of 1,0 mm, for half a minute each.

In order to ensure constant sifting, it is advisable to use a mechanical sieve, e.g. a vibrating table with fitted sieves.

The matter retained by the sieve with slotted perforations of 3,5 mm and that passing through the sieve with slotted perforations of 1,0 mm must be weighed together and regarded as extraneous matter. Where the matter retained by the sieve with slotted perforations of 3,5 mm includes parts of the ‘other cereals’ group or particularly large grains of the basic cereal, those parts or grains shall be returned to the sifted sample. During sifting, in the sieve with slotted perforations of 1,0 mm, a check must be made for live pests.

From the sifted sample, a sample of 50 to 100 g shall be taken using a separator. This partial sample must be weighed.

The partial sample should then be spread out on a table with tweezers or a horn spatula and broken grains, other cereals, sprouted grains, grains damaged by pests, grains damaged by frost, grains in which the germ is discoloured, mottled grains, extraneous seeds, ergots, damaged grains, decayed grains, husks and live pests and dead insects must be extracted.

Where the partial sample includes grains still in the husk, they shall be husked by hand, the husks obtained being considered as pieces of husks. Stones, sand and fragments of straw shall be considered extraneous matter.

The partial sample shall be passed for half a minute through a sieve with a mesh size of 1,9 mm for common wheat. Matter which passes through this sieve shall be considered as shrivelled grains. Grains damaged by frost and unripe green grains shall belong to the ‘shrivelled grains’ group.

1.2.   Groups of matter other than basic cereals of unimpaired quality, determined according to the methods referred to in point 1 must be weighed very carefully to the nearest 0,01 g and distributed according to percentage over the average sample. The particulars entered in the analysis report shall be to the nearest 0,1 %. Check for live pests.

As a general rule, two analyses must be made for each sample. They must not differ by more than 10 % in respect of the total of the abovementioned matter.

1.3.   The apparatus to be used for the operations referred to in points 1 and 2 is as follows:

| (a) | sample separator, e.g. a conical or grooved apparatus; |
| --- | --- |

(a)

sample separator, e.g. a conical or grooved apparatus;

| (b) | precision or assay balance; |
| --- | --- |

(b)

precision or assay balance;

| (c) | sieves with slotted perforations of 1,0 mm, 1,8 mm, 1,9 mm, 2,0 mm, 2,2 mm and 3,5 mm and sieves with a 1,8 mm and 4,5 mm round mesh. The sieves may be fitted to a vibrating table. |
| --- | --- |

(c)

sieves with slotted perforations of 1,0 mm, 1,8 mm, 1,9 mm, 2,0 mm, 2,2 mm and 3,5 mm and sieves with a 1,8 mm and 4,5 mm round mesh. The sieves may be fitted to a vibrating table.

PART B

2.   STANDARD METHOD FOR DETERMINING THE MOISTURE CONTENT OF DURUM WHEAT

The standard method for determining the moisture content of durum wheat is that given below. However, Member States may also use other methods based on the same principle or method ISO 712:1998 or a method based on infra-red technology. In case of dispute, only the results obtained using the method set out in Annex II, Part B shall be accepted.

2.1.   Principle

The product is dried at a temperature of 130 to 133 °C under normal atmospheric pressure, for an appropriate period of time according to the size of the particles.

2.2.   Scope

This drying method is used for cereals crushed into particles of which at least 50 % pass through a sieve with 0,5 mm mesh and leave not more than 10 % residue on the sieve with a 1,0 mm round mesh. It is also used for flour.

2.3.   Apparatus

Precision balance.

Crusher made of a material which does not absorb moisture, is easy to clean, enables crushing to be effected quickly and evenly without overheating, limits contact with the outside air to the minimum, and meets the requirements mentioned in 2 (e.g. a detachable roller mill).

Receptacle made of non-corrodible metal or glass, fitted with a sufficiently tight-fitting lid; working surface allowing distribution of the test sample at 0,3 g per square centimetre.

Electrically heated isothermic heating chamber, set at a temperature of 130 to 133 °C (1), having adequate ventilation (2).

Dessicator with a metal or, failing metal, porcelain plate (thick, perforated), containing any suitable dessicant.

2.4.   Procedure

Drying

Weigh to the nearest 1 mg a quantity of approximately than 5 g of the crushed small-grained cereals or 8 g of the crushed maize in the pre-weighed receptacle. Place the receptacle in a heating chamber heated to a temperature of 130 to 133 °C. This should be done as quickly as possible, so as to prevent too great a drop in temperature. Leave small-grained cereals to dry for two hours and maize for four hours after the heating chamber regains a temperature of 130 to 133 °C. Remove the receptacle from the heating chamber, quickly replace the lid, leave to cool for 30 to 45 minutes in a dessicator and weigh (to the nearest 1 mg).

2.5.   Method of calculation and formulae

| E | = | the initial mass, in grams, of the test sample |
| --- | --- | --- |
| M | = | the mass, in grams, of the test sample after preparation |
| M′ | = | the mass, in grams, of the test sample after crushing |
| m | = | the mass, in grams, of the dry test sample |

E

=

the initial mass, in grams, of the test sample

M

=

the mass, in grams, of the test sample after preparation

M′

=

the mass, in grams, of the test sample after crushing

m

=

the mass, in grams, of the dry test sample

The moisture content as a percentage of the product is equal to:

| — | without previous preparation (E – m) × 100/E, |
| --- | --- |

—

without previous preparation (E – m) × 100/E,

| — | with previous preparation [(M′ – m)M/M′ + E – M] × 100/E = 100 (1 – Mm/EM′) |
| --- | --- |

—

with previous preparation [(M′ – m)M/M′ + E – M] × 100/E = 100 (1 – Mm/EM′)

Tests to be made in duplicate at least.

2.6.   Repetition

The difference between the values obtained from the two determinations carried out simultaneously or in rapid succession by the same analyst shall not exceed 0,15 g of moisture per 100 g of sample. If it does so, the determinations shall be repeated.

PART C

3.   STANDARD METHOD FOR DETERMINING THE RATE OF PIEBALDING OF DURUM WHEAT

The standard method for determining the rate of piebalding of durum wheat is that given below.

3.1.   Principle

Only part of the sample is used to determine the percentage of grains which have been subject to total or partial piebalding. The grains are cut using a Pohl grain cutter or an equivalent instrument.

3.2.   Equipment and apparatus

| — | Pohl grain cutter or equivalent instrument, |
| --- | --- |

—

Pohl grain cutter or equivalent instrument,

| — | tweezers, scalpel, |
| --- | --- |

—

tweezers, scalpel,

| — | tray or dish. |
| --- | --- |

—

tray or dish.

3.3.   Procedure

| (a) | The determination is carried out on a sample of 100 grams after separation of any matter other than basic cereals of unimpaired quality. |
| --- | --- |

(a)

The determination is carried out on a sample of 100 grams after separation of any matter other than basic cereals of unimpaired quality.

| (b) | Spread the sample on a tray and homogenise well. |
| --- | --- |

(b)

Spread the sample on a tray and homogenise well.

| (c) | Insert a plate in the grain cutter and spread a handful of grains on the grid. Tap firmly to ensure that there is only one grain in each hole. Lower the movable section to hold the grains in place and then cut them. |
| --- | --- |

(c)

Insert a plate in the grain cutter and spread a handful of grains on the grid. Tap firmly to ensure that there is only one grain in each hole. Lower the movable section to hold the grains in place and then cut them.

| (d) | Prepare sufficient plates to ensure that a minimum of 600 grains are cut. |
| --- | --- |

(d)

Prepare sufficient plates to ensure that a minimum of 600 grains are cut.

| (e) | Count the number of grains which have been subject to total or partial piebalding. |
| --- | --- |

(e)

Count the number of grains which have been subject to total or partial piebalding.

| (f) | Calculate the percentage of grains which have been subject to total or partial piebalding. |
| --- | --- |

(f)

Calculate the percentage of grains which have been subject to total or partial piebalding.

3.4.   Expression of results

| I | = | mass, in grams, of matter other than basic cereals of unimpaired quality, and |
| --- | --- | --- |
| M | = | percentage of cleaned grains examined which have been subject to total or partial piebalding |

I

=

mass, in grams, of matter other than basic cereals of unimpaired quality, and

M

=

percentage of cleaned grains examined which have been subject to total or partial piebalding

3.5.   Result

The percentage of grains which have been subject to total or partial piebalding in the test portion is:

[M × (100 – I)]/100 = ...

PART D

4.   OTHER METHODS APPLICABLE TO DETERMINING THE QUALITY OF DURUM WHEAT

4.1.   The method for determining the Hagberg falling number (amylase activity test) shall comply with ISO 3093:2004.

4.2.   The standard method for determining the specific weight shall comply with ISO 7971/2:1995.

4.3.   The methods of taking samples and analysis for establishing the rate of mycotoxins are those referred to in the Annex to Regulation (EC) No 1881/2006 and set out in Annexes I and II to Commission Regulation (EC) No 401/2006 (3).

---

(1)  Air temperatures inside the heating chamber.

(2)  Its heating capacity should be such that, when it has been pre-set to a temperature of 130 to 133 °C, that temperature can be regained in less than 45 minutes after the maximum number of test samples have been placed in the chamber to dry simultaneously. Ventilation should be such that, when small-grained cereals (common wheat, durum wheat, barley and sorghum) are dried for two hours and maize for four hours, the results from all the test samples of semolina or, as the case may be, maize that the heating chamber can hold differ by less than 0,15 % from the results obtained after drying small-grained cereals for three hours and maize for five hours.

(3)  OJ L 70, 9.3.2006, p. 12.

---

ANNEX III

(Article 15(2)(a))

PART A

BASIC MILLING YIELD OF RICE

In order to be sound, fair and of marketable quality, the milling yield of the rice must not be lower by five points than that of the basic yields set out below.

| Name of variety | Whole-grain yield
  (%) | Overall yield
  (%) |
| --- | --- | --- |
| Argo, Selenio, Couachi | 66 | 73 |
| Alpe, Arco, Balilla, Balilla GG, Balilla Sollana, Bomba, Bombon, Colina, Elio, Flipper, Frances, Lido, Riso, Matusaka, Monticili, Pegonil, Sara, Strella, Thainato, Thaiperla, Ticinese, Veta, LEDA, Mareny, Clot, Albada, Guadiamar | 65 | 73 |
| Ispaniki A, Makedonia | 64 | 73 |
| Bravo, Europa, Loto, Riva, Rosa Marchetti, Savio, Veneria | 63 | 72 |
| Tolima | 63 | 71 |
| Inca | 63 | 70 |
| ALFA, Ariete, Bahia, Carola, Cigalon, Corallo, Cripto, Cristal, Drago, Eolo, Girona, Gladio, Graldo, Indio, Italico, Jucar, Koral, Lago, Lemont, Mercurio, Miara, Molo, Navile, Niva, Onda, Padano, Panda, Pierina, Marchetti, Ribe, Ringo, Rio, S. Andrea, Saturno, Senia, Sequial, Smeraldo, Star, Stirpe, Vela, Vitro, Calca, Dion, Zeus | 62 | 72 |
| Strymonas | 62 | 71 |
| Anseatico, Baldo, Belgioioso, Betis, Euribe, Italpatna, Marathon, Redi, Ribello, Rizzotto, Rocca, Roma, Romanico, Romeo, Tebre, Volano | 61 | 72 |
| Bonnet Bell, Rita, Silla, Thaibonnet, L 202, Puntal | 60 | 72 |
| Evropi, Melas | 60 | 70 |
| Arborio, Blue Belle, Blue Belle ‘E’, Blue Bonnet, Calendal, Razza 82, Rea | 58 | 72 |
| Maratelli, Precoce Rossi | 58 | 70 |
| Carnaroli, Elba, Vialone Nano | 57 | 72 |
| Axios | 57 | 67 |
| Roxani | 57 | 66 |
| Pygmalion | 52 | 71 |
| Unnamed varieties | 64 | 72 |

Name of variety

Whole-grain yield

(%)

Overall yield

(%)

Argo, Selenio, Couachi

66

73

Alpe, Arco, Balilla, Balilla GG, Balilla Sollana, Bomba, Bombon, Colina, Elio, Flipper, Frances, Lido, Riso, Matusaka, Monticili, Pegonil, Sara, Strella, Thainato, Thaiperla, Ticinese, Veta, LEDA, Mareny, Clot, Albada, Guadiamar

65

73

Ispaniki A, Makedonia

64

73

Bravo, Europa, Loto, Riva, Rosa Marchetti, Savio, Veneria

63

72

Tolima

63

71

Inca

63

70

ALFA, Ariete, Bahia, Carola, Cigalon, Corallo, Cripto, Cristal, Drago, Eolo, Girona, Gladio, Graldo, Indio, Italico, Jucar, Koral, Lago, Lemont, Mercurio, Miara, Molo, Navile, Niva, Onda, Padano, Panda, Pierina, Marchetti, Ribe, Ringo, Rio, S. Andrea, Saturno, Senia, Sequial, Smeraldo, Star, Stirpe, Vela, Vitro, Calca, Dion, Zeus

62

72

Strymonas

62

71

Anseatico, Baldo, Belgioioso, Betis, Euribe, Italpatna, Marathon, Redi, Ribello, Rizzotto, Rocca, Roma, Romanico, Romeo, Tebre, Volano

61

72

Bonnet Bell, Rita, Silla, Thaibonnet, L 202, Puntal

60

72

Evropi, Melas

60

70

Arborio, Blue Belle, Blue Belle ‘E’, Blue Bonnet, Calendal, Razza 82, Rea

58

72

Maratelli, Precoce Rossi

58

70

Carnaroli, Elba, Vialone Nano

57

72

Axios

57

67

Roxani

57

66

Pygmalion

52

71

Unnamed varieties

64

72

PART B

MAXIMUM PERCENTAGES OF RICE DEFECTS

In order to be sound, fair and of marketable quality, the percentages of miscellaneous impurities, the percentage of grains of rice from other varieties and the percentage of grains which are not of unimpaired quality as defined in Annex III to Regulation (EC) No 1234/2007 may not exceed the maximum percentages indicated below, for each type of rice.

‘Miscellaneous impurities’ shall be understood as any foreign matter other than rice.

| Grain defects | Round-grain rice
  CN code 1006 10 92 | Medium and long-grain A
  CN codes 1006 10 94 and 1006 10 96 | Long-grain B
  CN code 1006 10 98 |
| --- | --- | --- | --- |
| Chalky grains | 6 | 4 | 4 |
| Grains striated with red | 10 | 5 | 5 |
| Spotted and stained grains | 4 | 2,75 | 2,75 |
| Amber grains | 1 | 0,50 | 0,50 |
| Yellow grains | 0,175 | 0,175 | 0,175 |
| Miscellaneous impurities | 1 | 1 | 1 |
| Rice grains of other varieties | 5 | 5 | 5 |

Grain defects

Round-grain rice

CN code 1006 10 92

Medium and long-grain A

CN codes 1006 10 94 and 1006 10 96

Long-grain B

CN code 1006 10 98

Chalky grains

6

4

4

Grains striated with red

10

5

5

Spotted and stained grains

4

2,75

2,75

Amber grains

1

0,50

0,50

Yellow grains

0,175

0,175

0,175

Miscellaneous impurities

1

1

1

Rice grains of other varieties

5

5

5

---

ANNEX IV

(Article 19(1))

INCREASES AND REDUCTIONS IN THE PRICE OF DURUM WHEAT

Increases and reductions in the price of durum wheat are to be applied jointly using the amounts given below:

| (a) | when the moisture rate of durum wheat offered for buying-in is less than 14 %, the reductions to be applied shall be those given in table 1 below:

  Table 1


  Reductions due to the moisture content of durum wheat







  Moisture content
  (%) | Reductions
  (EUR/t) |
| --- | --- | --- |
| 13,4 | 0,1 |
| 13,3 | 0,2 |
| 13,2 | 0,3 |
| 13,1 | 0,4 |
| 13,0 | 0,5 |
| 12,9 | 0,6 |
| 12,8 | 0,7 |
| 12,7 | 0,8 |
| 12,6 | 0,9 |
| 12,5 | 1,0 |
| 12,4 | 1,1 |
| 12,3 | 1,2 |
| 12,2 | 1,3 |
| 12,1 | 1,4 |
| 12,0 | 1,5 |
| 11,9 | 1,6 |
| 11,8 | 1,7 |
| 11,7 | 1,8 |
| 11,6 | 1,9 |
| 11,5 | 2,0 |
| 11,4 | 2,1 |
| 11,3 | 2,2 |
| 11,2 | 2,3 |
| 11,1 | 2,4 |
| 11,0 | 2,5 |
| 10,9 | 2,6 |
| 10,8 | 2,7 |
| 10,7 | 2,8 |
| 10,6 | 2,9 |
| 10,5 | 3,0 |
| 10,4 | 3,1 |
| 10,3 | 3,2 |
| 10,2 | 3,3 |
| 10,1 | 3,4 |
| 10,0 | 3,5 |

(a)

when the moisture rate of durum wheat offered for buying-in is less than 14 %, the reductions to be applied shall be those given in table 1 below:

Table 1

Reductions due to the moisture content of durum wheat

Moisture content

(%)

Reductions

(EUR/t)

13,4

0,1

13,3

0,2

13,2

0,3

13,1

0,4

13,0

0,5

12,9

0,6

12,8

0,7

12,7

0,8

12,6

0,9

12,5

1,0

12,4

1,1

12,3

1,2

12,2

1,3

12,1

1,4

12,0

1,5

11,9

1,6

11,8

1,7

11,7

1,8

11,6

1,9

11,5

2,0

11,4

2,1

11,3

2,2

11,2

2,3

11,1

2,4

11,0

2,5

10,9

2,6

10,8

2,7

10,7

2,8

10,6

2,9

10,5

3,0

10,4

3,1

10,3

3,2

10,2

3,3

10,1

3,4

10,0

3,5

| (b) | if the moisture content exceeds 14 %, the reductions to be applied are those listed in table 2 below:

  Table 2


  Reductions due to the moisture content of durum wheat







  Moisture content
  (%) | Price reduction
  (EUR/t) |
| --- | --- | --- |
| 14,5 | 1,0 |
| 14,4 | 0,8 |
| 14,3 | 0,6 |
| 14,2 | 0,4 |
| 14,1 | 0,2 |

(b)

if the moisture content exceeds 14 %, the reductions to be applied are those listed in table 2 below:

Table 2

Reductions due to the moisture content of durum wheat

Moisture content

(%)

Price reduction

(EUR/t)

14,5

1,0

14,4

0,8

14,3

0,6

14,2

0,4

14,1

0,2

| (c) | where the percentage of broken grains exceeds 3 % for durum wheat, a reduction of EUR 0,05 shall be applied for each additional 0,1 % percentage points; |
| --- | --- |

(c)

where the percentage of broken grains exceeds 3 % for durum wheat, a reduction of EUR 0,05 shall be applied for each additional 0,1 % percentage points;

| (d) | where the percentage of impurities found in grains exceeds 2 % for durum wheat, a reduction of EUR 0,05 shall be applied for each additional 0,1 % percentage points; |
| --- | --- |

(d)

where the percentage of impurities found in grains exceeds 2 % for durum wheat, a reduction of EUR 0,05 shall be applied for each additional 0,1 % percentage points;

| (e) | where the percentage of sprouted grains exceeds 2,5 %, a reduction of EUR 0,05 shall be applied for each additional 0,1 % percentage points; |
| --- | --- |

(e)

where the percentage of sprouted grains exceeds 2,5 %, a reduction of EUR 0,05 shall be applied for each additional 0,1 % percentage points;

| (f) | where the percentage of miscellaneous impurities (Schwarzbesatz) found in grains exceeds 0,5 % for durum wheat, a reduction of EUR 0,1 shall be applied for each additional 0,1 % percentage points; |
| --- | --- |

(f)

where the percentage of miscellaneous impurities (Schwarzbesatz) found in grains exceeds 0,5 % for durum wheat, a reduction of EUR 0,1 shall be applied for each additional 0,1 % percentage points;

| (g) | where the percentage of piebald grains in durum wheat exceeds 20 %, a reduction of EUR 0,2 shall be applied for each additional percentage point or fraction thereof. |
| --- | --- |

(g)

where the percentage of piebald grains in durum wheat exceeds 20 %, a reduction of EUR 0,2 shall be applied for each additional percentage point or fraction thereof.

---

ANNEX V

(Article 19(1))

INCREASES AND REDUCTIONS IN THE PRICE OF RICE

| 1. | The increases or reductions in the price of rice shall apply to the intervention price of paddy rice offered for buying-in by multiplying the latter by the sum of the percentages of reductions and increases determined as follows:






  (a) | where the milling yield of the rice differs from the basic milling yield for the variety concerned as set out in Part A of Annex III to this Regulation, the price increases and reductions to be applied shall be those shown in Table 1 below, in respect of each variety of rice;

  Table 1


  Reductions and increases relating to the milling yield of rice







  Yield of whole-grain milled paddy rice | Price increases and reductions per yield point |
| --- | --- | --- | --- |
| Above the basic yield | 0,75 % increase |
| Below the basic yield | 1 % reduction |

1.

The increases or reductions in the price of rice shall apply to the intervention price of paddy rice offered for buying-in by multiplying the latter by the sum of the percentages of reductions and increases determined as follows:

(a)

where the milling yield of the rice differs from the basic milling yield for the variety concerned as set out in Part A of Annex III to this Regulation, the price increases and reductions to be applied shall be those shown in Table 1 below, in respect of each variety of rice;

Table 1

Reductions and increases relating to the milling yield of rice

Yield of whole-grain milled paddy rice

Price increases and reductions per yield point

Above the basic yield

0,75 % increase

Below the basic yield

1 % reduction

| Overall yield of milled paddy rice | Price increases and reductions per yield point |
| --- | --- |
| Above the basic yield | 0,60 % increase |
| Below the basic yield | 0,80 % reduction |

Overall yield of milled paddy rice

Price increases and reductions per yield point

Above the basic yield

0,60 % increase

Below the basic yield

0,80 % reduction

| (b) | where the defects in the grains of paddy rice exceed the permitted tolerances for the standard quality of paddy rice, the percentage reduction to be applied to the intervention price shall be as set out in Table 2 below, per type of rice;

  Table 2


  Price reductions for defective rice grains










  Grain defects | Percentage of defective grains resulting in a reduction in the intervention price | Percentage reduction (1) applicable to the additional discrepancy beyond the lower limit |
| --- | --- | --- | --- |
| Round-grain rice
  CN code 1006 10 92 | Medium and long-grain A
  CN codes 1006 10 94 and 1006 10 96 | Long-grain B
  CN code 1006 10 98 |
| Chalky grains | from 2 to 6 % | from 2 to 4 % | from 1,5 % to 4 % | 1 % for each additional 0,5 % discrepancy |
| Grains striated with red | from 1 % to 10 % | from 1 % to 5 % | from 1 % to 5 % | 1 % for each additional 1 % discrepancy |
| Spotted and stained grains | from 0,50 % to 4 % | from 0,50 % to 2,75 % | from 0,50 % to 2,75 % | 0,8 % for each additional 0,25 % discrepancy |
| Amber grains | from 0,05 % to 1 % | from 0,05 % to 0,50 % | from 0,05 % to 0,50 % | 1,25 % for each additional 0,25 % discrepancy |
| Yellow grains | from 0,02 % to 0,175 % | from 0,02 % to 0,175 % | from 0,02 % to 0,175 % | 6 % for each additional 0,125 % discrepancy |

(b)

where the defects in the grains of paddy rice exceed the permitted tolerances for the standard quality of paddy rice, the percentage reduction to be applied to the intervention price shall be as set out in Table 2 below, per type of rice;

Table 2

Price reductions for defective rice grains

Grain defects

Percentage of defective grains resulting in a reduction in the intervention price

Percentage reduction (1) applicable to the additional discrepancy beyond the lower limit

Round-grain rice

CN code 1006 10 92

Medium and long-grain A

CN codes 1006 10 94 and 1006 10 96

Long-grain B

CN code 1006 10 98

Chalky grains

from 2 to 6 %

from 2 to 4 %

from 1,5 % to 4 %

1 % for each additional 0,5 % discrepancy

Grains striated with red

from 1 % to 10 %

from 1 % to 5 %

from 1 % to 5 %

1 % for each additional 1 % discrepancy

Spotted and stained grains

from 0,50 % to 4 %

from 0,50 % to 2,75 %

from 0,50 % to 2,75 %

0,8 % for each additional 0,25 % discrepancy

Amber grains

from 0,05 % to 1 %

from 0,05 % to 0,50 %

from 0,05 % to 0,50 %

1,25 % for each additional 0,25 % discrepancy

Yellow grains

from 0,02 % to 0,175 %

from 0,02 % to 0,175 %

from 0,02 % to 0,175 %

6 % for each additional 0,125 % discrepancy

| (c) | where the moisture content of the paddy rice exceeds 13 %, the percentage reduction in its intervention price shall be equal to the difference between the percentage moisture content of the paddy rice offered for intervention, measured to one decimal point, and 13 %; |
| --- | --- |

(c)

where the moisture content of the paddy rice exceeds 13 %, the percentage reduction in its intervention price shall be equal to the difference between the percentage moisture content of the paddy rice offered for intervention, measured to one decimal point, and 13 %;

| (d) | where the percentage of miscellaneous impurities in the paddy rice exceeds 0,1 %, it shall be bought in with a reduction in the intervention price of 0,02 % for each additional 0,01 % difference; |
| --- | --- |

(d)

where the percentage of miscellaneous impurities in the paddy rice exceeds 0,1 %, it shall be bought in with a reduction in the intervention price of 0,02 % for each additional 0,01 % difference;

| (e) | where a batch of paddy rice is offered for intervention for a particular variety but includes grains of other varieties exceeding 3 %, the batch shall be bought in with a 0,1 % reduction in the intervention price for each additional 0,1 % difference. |
| --- | --- |

(e)

where a batch of paddy rice is offered for intervention for a particular variety but includes grains of other varieties exceeding 3 %, the batch shall be bought in with a 0,1 % reduction in the intervention price for each additional 0,1 % difference.

| 2. | The reductions and increases referred to in paragraph 1 shall be established on the basis of the weighted average of the test results on the representative samples as defined in Article 16. |
| --- | --- |

2.

The reductions and increases referred to in paragraph 1 shall be established on the basis of the weighted average of the test results on the representative samples as defined in Article 16.

---

(1)  Each discrepancy is calculated from the percentage of defective grains, to the second decimal place.

---

ANNEX VI

(Article 27, second subparagraph)

Correlation table

| Regulation (EC) No 489/2005 | This Regulation |
| --- | --- |
| Article 1 | — |
| Article 2(1) | Article 4(2)(a) and (b) |
| Article 2(2) | — |
| Article 3(1) | Article 15(1) |
| Article 3(2) | Article 15(2) |
| Article 3(3) | Annex III, Part B |
| Article 4 | Annex V |
| Article 5 | — |
| Article 6(1), first subparagraph | Article 4(1) |
| Article 6(1), second subparagraph | — |
| Article 6(2) and (3) | Article 4(2)(a) |
| Article 6(4) | Article 4(3) |
| Article 6(5) | Article 5(1) |
| Article 7 | — |
| Article 8(1) and (2) | Article 11(1) |
| Article 8(3) | — |
| Article 9(1) | Article 10(1), first subparagraph |
| Article 9(2), first subparagraph | Article 10(2) |
| Article 9(2), second subparagraph | — |
| Article 9(3) | Article 10(3) |
| Article 10(1) | Article 17(1) |
| Article 10(2) | Article 10(4), first subparagraph |
| Article 10(3) | Article 10(4), second subparagraph |
| Article 11 | — |
| Article 12(1) and (2) | Article 16(1) and (2) |
| Article 12(3) | — |
| Article 13(1), first subparagraph | Article 14 |
| Article 13(1), second subparagraph | Article 16(4) |
| Article 13(2) | Article 16(5) |
| Article 14 | Article 18 |
| Article 15(1), first subparagraph | Article 19(1), first subparagraph |
| Article 15(1), second subparagraph | — |
| Article 15(2), first and second subparagraphs | Article 19(2) |
| Article 15(2) third subparagraph | Article 19(2) third subparagraph |
| Article 16 | — |
| Article 17 | Article 16(3) |
| Article 18 | Article 21 |
| Annex I | — |
| Annex II, Part A | Annex III, Part A |
| Annex II, Part B | Annex V |
| Annex III | Annex III, Part B |
| Annex IV | Annex V |
| Annex V | — |
| Annex VI | — |

Regulation (EC) No 489/2005

This Regulation

Article 1

—

Article 2(1)

Article 4(2)(a) and (b)

Article 2(2)

—

Article 3(1)

Article 15(1)

Article 3(2)

Article 15(2)

Article 3(3)

Annex III, Part B

Article 4

Annex V

Article 5

—

Article 6(1), first subparagraph

Article 4(1)

Article 6(1), second subparagraph

—

Article 6(2) and (3)

Article 4(2)(a)

Article 6(4)

Article 4(3)

Article 6(5)

Article 5(1)

Article 7

—

Article 8(1) and (2)

Article 11(1)

Article 8(3)

—

Article 9(1)

Article 10(1), first subparagraph

Article 9(2), first subparagraph

Article 10(2)

Article 9(2), second subparagraph

—

Article 9(3)

Article 10(3)

Article 10(1)

Article 17(1)

Article 10(2)

Article 10(4), first subparagraph

Article 10(3)

Article 10(4), second subparagraph

Article 11

—

Article 12(1) and (2)

Article 16(1) and (2)

Article 12(3)

—

Article 13(1), first subparagraph

Article 14

Article 13(1), second subparagraph

Article 16(4)

Article 13(2)

Article 16(5)

Article 14

Article 18

Article 15(1), first subparagraph

Article 19(1), first subparagraph

Article 15(1), second subparagraph

—

Article 15(2), first and second subparagraphs

Article 19(2)

Article 15(2) third subparagraph

Article 19(2) third subparagraph

Article 16

—

Article 17

Article 16(3)

Article 18

Article 21

Annex I

—

Annex II, Part A

Annex III, Part A

Annex II, Part B

Annex V

Annex III

Annex III, Part B

Annex IV

Annex V

Annex V

—

Annex VI

—

---

| 25.7.2009 | EN | Official Journal of the European Union | L 194/47 |
| --- | --- | --- | --- |

25.7.2009

EN

Official Journal of the European Union

L 194/47

---

COMMISSION REGULATION (EC) No 671/2009

of 24 July 2009

opening the procedure for the allocation of export licences for cheese to be exported to the United States of America in 2010 under certain GATT quotas

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 171(1) thereof, in conjunction with Article 4,

Whereas:

| (1) | Section 2 of Chapter III of Commission Regulation (EC) No 1282/2006 of 17 August 2006 laying down special detailed rules for the application of Council Regulation (EC) No 1255/1999 as regards export licences and export refunds for milk and milk products (2) provides that export licences for cheese exported to the United States of America as part of the quotas under the agreements concluded during multilateral trade negotiations may be allocated according to a special procedure by which preferred importers in the USA may be designated. |
| --- | --- |

(1)

Section 2 of Chapter III of Commission Regulation (EC) No 1282/2006 of 17 August 2006 laying down special detailed rules for the application of Council Regulation (EC) No 1255/1999 as regards export licences and export refunds for milk and milk products (2) provides that export licences for cheese exported to the United States of America as part of the quotas under the agreements concluded during multilateral trade negotiations may be allocated according to a special procedure by which preferred importers in the USA may be designated.

| (2) | That procedure should be opened for exports during 2010 and the additional rules relating to it should be determined. |
| --- | --- |

(2)

That procedure should be opened for exports during 2010 and the additional rules relating to it should be determined.

| (3) | In administering imports the competent authorities in the USA make a distinction between the additional quota granted to the European Community under the Uruguay Round and the quotas resulting from the Tokyo Round. Export licences should be allocated taking into account the eligibility of those products for the USA quota in question as described in the Harmonised Tariff Schedule of the United States of America. |
| --- | --- |

(3)

In administering imports the competent authorities in the USA make a distinction between the additional quota granted to the European Community under the Uruguay Round and the quotas resulting from the Tokyo Round. Export licences should be allocated taking into account the eligibility of those products for the USA quota in question as described in the Harmonised Tariff Schedule of the United States of America.

| (4) | With a view to exporting the maximum quantity under the quotas for which there is moderate interest, applications covering the whole quota quantity should be allowed. |
| --- | --- |

(4)

With a view to exporting the maximum quantity under the quotas for which there is moderate interest, applications covering the whole quota quantity should be allowed.

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

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of Agricultural Markets,

HAS ADOPTED THIS REGULATION:

Article 1

Export licences for products falling within CN code 0406 and listed in Annex I to this Regulation to be exported to the United States of America in 2010 under the quotas referred to in Article 23 of Regulation (EC) No 1282/2006 shall be issued in accordance with Section 2 of Chapter III of that Regulation and with the provisions of this Regulation.

Article 2

1.   Applications for licences referred to in Article 24 of Regulation (EC) No 1282/2006 (hereinafter referred to as ‘applications’) shall be lodged with the competent authorities from 1 to 10 September 2009 at the latest.

2.   Applications shall be admissible only if they contain all the information referred to in Article 24 of Regulation (EC) No 1282/2006 and if they are accompanied by the documents referred to therein.

Where, for the same group of products referred to in column 2 of Annex I to this Regulation the available quantity is divided between the Uruguay Round quota and the Tokyo Round quota, licence applications may cover only one of those quotas and shall indicate the quota concerned, specifying the identification of the group and of the quota indicated in column 3 of that Annex.

Information referred to in Article 24 of Regulation (EC) No 1282/2006 shall be presented in accordance with the model set out in Annex II to this Regulation.

3.   As regards the quotas identified by 22-Tokyo, 22-Uruguay, 25-Tokyo and 25-Uruguay in column 3 of Annex I, applications shall cover at least 10 tonnes and shall not exceed the quantity available under the quota concerned as set out in column 4 of that Annex.

As regards the other quotas indicated in column 3 of Annex I, applications shall cover at least 10 tonnes and no more than 40 % of the quantity available under the quota concerned as set out in column 4 of that Annex.

4.   Applications shall be admissible only if applicants declare in writing that they have not lodged other applications for the same group of products and the same quota and undertake not to do so.

If an applicant lodges several applications for the same group of products and the same quota in one or more Member States, all his applications shall be deemed inadmissible.

Article 3

1.   Member States shall notify the Commission, within five working days after the end of the period for lodging applications, of the applications lodged for each of the groups of products and, where applicable, the quotas indicated in Annex I.

All notifications, including ‘nil’ notifications, shall be made by fax or e-mail on the model form set out in Annex III.

2.   Notification shall comprise for each group and, where applicable, for each quota:

| (a) | a list of applicants; |
| --- | --- |

(a)

a list of applicants;

| (b) | the quantities applied for by each applicant broken down by the product code of the Combined Nomenclature and by their code in accordance with the Harmonised Tariff Schedule of the United States of America (2009); |
| --- | --- |

(b)

the quantities applied for by each applicant broken down by the product code of the Combined Nomenclature and by their code in accordance with the Harmonised Tariff Schedule of the United States of America (2009);

| (c) | the name and address of the importer designated by the applicant. |
| --- | --- |

(c)

the name and address of the importer designated by the applicant.

Article 4

The Commission shall, pursuant to Article 25 of Regulation (EC) No 1282/2006, determine the allocation of licences without delay and shall notify the Member States thereof by 31 October 2009 at the latest.

Member States shall notify the Commission, within five working days after publication of the allocation coefficients, for each group and, where applicable, for each quota, the quantities allocated by applicant, in accordance to Article 25 of Regulation (EC) No 1282/2006.

The notification shall be made by fax or e-mail on the model form set out in Annex IV to this Regulation.

Article 5

The information notified under Article 3 of this Regulation and under Article 24 of Regulation (EC) No 1282/2006 shall be verified by the Member States before the licences are issued and by 15 December 2009 at the latest.

Where it is found that incorrect information has been supplied by an operator to whom a licence has been issued, the licence shall be cancelled and the security forfeited. The Member States shall communicate it to the Commission without any delay.

Article 6

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, 24 July 2009.

For the Commission

Mariann FISCHER BOEL

Member of the Commission

---

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

1

(2)  OJ L 234, 29.8.2006, p. 4.

2

---

ANNEX I

Cheese to be exported to the United States of America in 2010 under certain GATT quotas

Section 2 of Chapter III of Regulation (EC) No 1282/2006 and Regulation (EC) No 671/2009

| Identification of group in accordance with Additional Notes in Chapter 4 of the Harmonised Tariff Schedule of the United States | Identification of group and quota | Quantity available for 2010 |
| --- | --- | --- |
| Note to | Group | | Tonnes |
| (1) | (2) | (3) | (4) |
| 16 | Not specifically provided for (NSPF) | 16-Tokyo | 908,877 |
| 16-Uruguay | 3 446,000 |
| 17 | Blue Mould | 17 | 350,000 |
| 18 | Cheddar | 18 | 1 050,000 |
| 20 | Edam/Gouda | 20 | 1 100,000 |
| 21 | Italian type | 21 | 2 025,000 |
| 22 | Swiss or Emmenthaler cheese other than with eye formation | 22-Tokyo | 393,006 |
| 22-Uruguay | 380,000 |
| 25 | Swiss or Emmenthaler cheese with eye formation | 25-Tokyo | 4 003,172 |
| 25-Uruguay | 2 420,000 |

Identification of group in accordance with Additional Notes in Chapter 4 of the Harmonised Tariff Schedule of the United States

Identification of group and quota

Quantity available for 2010

Note to

Group

Tonnes

(1)

(2)

(3)

(4)

16

Not specifically provided for (NSPF)

16-Tokyo

908,877

16-Uruguay

3 446,000

17

Blue Mould

17

350,000

18

Cheddar

18

1 050,000

20

Edam/Gouda

20

1 100,000

21

Italian type

21

2 025,000

22

Swiss or Emmenthaler cheese other than with eye formation

22-Tokyo

393,006

22-Uruguay

380,000

25

Swiss or Emmenthaler cheese with eye formation

25-Tokyo

4 003,172

25-Uruguay

2 420,000

---

ANNEX II

Presentation of information required pursuant to Article 24 of Regulation (EC) No 1282/2006

| Identification of group and quota referred to in column 3 of Annex I to Regulation (EC) No 671/2009: | |
| --- | --- |

Identification of group and quota referred to in column 3 of Annex I to Regulation (EC) No 671/2009:

Name of group indicated in column 2 of Annex I to Regulation (EC) No 671/2009: ...

...

| Origin of quota: | Uruguay Round:  | Tokyo Round:  |
| --- | --- | --- |

Origin of quota:

Uruguay Round: 

Tokyo Round: 

| Name/address of applicant | Product code of the Combined Nomenclature | Quantity applied for in tonnes | Harmonised Tariff
  Schedule of the USA code | Name/address of designated importer |
| --- | --- | --- | --- | --- |
| | | | | |
| | | |
| | | |
| Total: | | |

Name/address of applicant

Product code of the Combined Nomenclature

Quantity applied for in tonnes

Harmonised Tariff

Schedule of the USA code

Name/address of designated importer

Total:

---

ANNEX III

Presentation of information required pursuant to Article 3 of Regulation (EC) No 671/2009

To be sent to + 32 2 295 3310 or AGRI-MILK-USA@ec.europa.eu

| Identification of group and quota referred to in column 3 of Annex I to Regulation (EC) No 671/2009: | |
| --- | --- |

Identification of group and quota referred to in column 3 of Annex I to Regulation (EC) No 671/2009:

Name of group indicated in column 2 of Annex I to Regulation (EC) No 671/2009: ...

...

| Origin of quota: | Uruguay Round:  | Tokyo Round:  |
| --- | --- | --- |

Origin of quota:

Uruguay Round: 

Tokyo Round: 

| No | Name/address of Applicant | Product code of the Combined Nomenclature | Quantity applied for in tonnes | Harmonised Tariff Schedule of the USA code | Name/address designated importer |
| --- | --- | --- | --- | --- | --- |
| 1 | | | | | |
| | | |
| | | |
| Total: | | |
| 2 | | | | | |
| | | |
| | | |
| Total: | | |
| 3 | | | | | |
| | | |
| | | |
| Total: | | |
| 4 | | | | | |
| | | |
| | | |
| Total: | | |
| 5 | | | | | |
| | | |
| | | |
| Total: | | |

No

Name/address of Applicant

Product code of the Combined Nomenclature

Quantity applied for in tonnes

Harmonised Tariff Schedule of the USA code

Name/address designated importer

1

Total:

2

Total:

3

Total:

4

Total:

5

Total:

---

ANNEX IV

Presentation of granted licences in accordance to Article 25 of Regulation (EC) No 1282/2006

To be sent to + 32 2 295 3310 or AGRI-MILK-USA@ec.europa.eu

| Identification of group and quota referred to in column 3 of Annex I to Regulation (EC) No 671/2009 | Origin of the quota | Name/address of applicant | Product code of the Combined Nomenclature | Quantity applied for
  in tonnes | Name/address of designated importer | Allocated Quantity (1)

  in tonnes |
| --- | --- | --- | --- | --- | --- | --- |
| | Uruguay round
   | | | | | |
| | | |
| Tokyo round
   | | | |
| Total: | | Total: | |
| | Uruguay round
   | | | | | |
| | | |
| Tokyo round
   | | | |
| Total: | | Total: | |
| | Uruguay round
   | | | | | |
| | | |
| Tokyo round
   | | | |
| Total: | | Total: | |

Identification of group and quota referred to in column 3 of Annex I to Regulation (EC) No 671/2009

Origin of the quota

Name/address of applicant

Product code of the Combined Nomenclature

Quantity applied for

in tonnes

Name/address of designated importer

Allocated Quantity (1)

in tonnes

Uruguay round



Tokyo round



Total:

Total:

Uruguay round



Tokyo round



Total:

Total:

Uruguay round



Tokyo round



Total:

Total:

---

(1)  Quantities allocated by drawing lots shall be distributed among the individual CN codes in proportion to the quantities of product by CN code applied for.

---

| 25.7.2009 | EN | Official Journal of the European Union | L 194/53 |
| --- | --- | --- | --- |

25.7.2009

EN

Official Journal of the European Union

L 194/53

---

COMMISSION REGULATION (EC) No 672/2009

of 24 July 2009

on the issue of licences for importing rice under the tariff quotas opened for the July 2009 subperiod by Regulation (EC) No 327/98

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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

Having regard to Commission Regulation (EC) No 1301/2006 of 31 August 2006 laying down common rules for the administration of import tariff quotas for agricultural products managed by a system of import licences (2), and in particular Article 7(2) thereof,

Having regard to Commission Regulation (EC) No 327/98 of 10 February 1998 opening and providing for the administration of certain tariff quotas for imports of rice and broken rice (3), and in particular the first subparagraph of Article 5 thereof,

Whereas:

| (1) | Regulation (EC) No 327/98 opened and provided for the administration of certain import tariff quotas for rice and broken rice, broken down by country of origin and split into several subperiods in accordance with Annex IX to that Regulation. |
| --- | --- |

(1)

Regulation (EC) No 327/98 opened and provided for the administration of certain import tariff quotas for rice and broken rice, broken down by country of origin and split into several subperiods in accordance with Annex IX to that Regulation.

| (2) | July is the third subperiod for the quota laid down in Article 1(1)(a) of Regulation (EC) No 327/98 and the second subperiod for the quotas laid down in Article 1(1)(b), (c) and (d). |
| --- | --- |

(2)

July is the third subperiod for the quota laid down in Article 1(1)(a) of Regulation (EC) No 327/98 and the second subperiod for the quotas laid down in Article 1(1)(b), (c) and (d).

| (3) | The notifications presented under Article 8(a) of Regulation (EC) No 327/98 show that, for the quotas with order numbers 09.4154 – 09.4166, the applications lodged in the first ten working days of July 2009 under Article 4(1) of the Regulation cover a quantity greater than that available. The extent to which import licences may be issued should therefore be determined by establishing the allocation coefficient to be applied to the quantities requested under the quotas concerned. |
| --- | --- |

(3)

The notifications presented under Article 8(a) of Regulation (EC) No 327/98 show that, for the quotas with order numbers 09.4154 – 09.4166, the applications lodged in the first ten working days of July 2009 under Article 4(1) of the Regulation cover a quantity greater than that available. The extent to which import licences may be issued should therefore be determined by establishing the allocation coefficient to be applied to the quantities requested under the quotas concerned.

| (4) | It is also clear from the notifications that, for the quotas with order numbers 09.4127 – 09.4128 – 09.4129 – 09.4149 – 09.4150 – 09.4152 – 09.4153, the applications lodged in the first ten working days of July 2009 under Article 4(1) of Regulation (EC) No 327/98 cover a quantity less than that available. |
| --- | --- |

(4)

It is also clear from the notifications that, for the quotas with order numbers 09.4127 – 09.4128 – 09.4129 – 09.4149 – 09.4150 – 09.4152 – 09.4153, the applications lodged in the first ten working days of July 2009 under Article 4(1) of Regulation (EC) No 327/98 cover a quantity less than that available.

| (5) | The total quantities available for the following subperiod should therefore be fixed for the quotas with order numbers 09.4127 – 09.4128 - 09.4129 - 09.4130 – 09.4148 – 09.4112 – 09.4116 - 09.4117 - 09.4118 – 09.4119 – 09.4166, in accordance with the first subparagraph of Article 5 of Regulation (EC) No 327/98, |
| --- | --- |

(5)

The total quantities available for the following subperiod should therefore be fixed for the quotas with order numbers 09.4127 – 09.4128 - 09.4129 - 09.4130 – 09.4148 – 09.4112 – 09.4116 - 09.4117 - 09.4118 – 09.4119 – 09.4166, in accordance with the first subparagraph of Article 5 of Regulation (EC) No 327/98,

HAS ADOPTED THIS REGULATION:

Article 1

1.   For import licence applications for rice under the quotas with order numbers 09.4154 – 09.4166 as referred to in Regulation (EC) No 327/98 lodged in the first ten working days of July 2009, licences shall be issued for the quantities requested, multiplied by the allocation coefficients set out in the Annex to this Regulation.

2.   The total quantities available under the quotas with order numbers 09.4127 – 09.4128 – 09.4129 – 09.4130 – 09.4148 – 09.4112 – 09.4116 – 09.4117 – 09.4118 – 09.4119 – 09.4166 as referred to in Regulation (EC) No 327/98 for the next subperiod are set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day of 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, 24 July 2009.

For the Commission

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

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

1

(2)  OJ L 238, 1.9.2006, p. 13.

2

(3)  OJ L 37, 11.2.1998, p. 5.

3

---

ANNEX

Quantities to be allocated for the July 2009 subperiod and quantities available for the following subperiod under Regulation (EC) No 327/98

(a)   Quota of wholly milled or semi-milled rice falling within CN code 1006 30 provided for in Article 1(1)(a) of Regulation (EC) No 327/98:

| Origin | Order number | Allocation coefficient for the July 2009 subperiod | Total quantities available for September 2009 subperiod
  (kg) |
| --- | --- | --- | --- |
| United States of America | 09.4127 | — (1) | 13 879 202 |
| Thailand | 09.4128 | — (1) | 1 315 205 |
| Australia | 09.4129 | — (1) | 385 000 |
| Other origins | 09.4130 | — (2) | 0 |

Origin

Order number

Allocation coefficient for the July 2009 subperiod

Total quantities available for September 2009 subperiod

(kg)

United States of America

09.4127

— (1)

13 879 202

Thailand

09.4128

— (1)

1 315 205

Australia

09.4129

— (1)

385 000

Other origins

09.4130

— (2)

0

(b)   Quota for husked rice falling within CN code 1006 20 provided for in Article 1(1)(b) of Regulation (EC) No 327/98:

| Origin | Order number | Allocation coefficient for July 2009 subperiod | Total quantities available for October 2009 subperiod
  (kg) |
| --- | --- | --- | --- |
| All countries | 09.4148 | — (2) | 66 289 |

Origin

Order number

Allocation coefficient for July 2009 subperiod

Total quantities available for October 2009 subperiod

(kg)

All countries

09.4148

— (2)

66 289

(c)   Quota for broken rice falling within CN code 1006 40 provided for in Article 1(1)(c) of Regulation (EC) No 327/98:

| Origin | Order number | Allocation coefficient for July 2009 subperiod |
| --- | --- | --- |
| Thailand | 09.4149 | — (1) |
| Australia | 09.4150 | — (3) |
| Guyana | 09.4152 | — (3) |
| United States of America | 09.4153 | — (1) |
| Other origins | 09.4154 | 1,561628 % |

Origin

Order number

Allocation coefficient for July 2009 subperiod

Thailand

09.4149

— (1)

Australia

09.4150

— (3)

Guyana

09.4152

— (3)

United States of America

09.4153

— (1)

Other origins

09.4154

1,561628 %

(d)   Quota for wholly milled or semi-milled rice falling within CN code 1006 30 provided for in Article 1(1)(d) of Regulation (EC) No 327/98:

| Origin | Order number | Allocation coefficient for July 2009 subperiod | Total quantities available for September 2009 subperiod
  (kg) |
| --- | --- | --- | --- |
| Thailand | 09.4112 | — (2) | 0 |
| United States of America | 09.4116 | — (2) | 0 |
| India | 09.4117 | — (2) | 40 445 |
| Pakistan | 09.4118 | — (2) | 0 |
| Other origins | 09.4119 | — (2) | 0 |
| All countries | 09.4166 | 1,04385 % | 0 |

Origin

Order number

Allocation coefficient for July 2009 subperiod

Total quantities available for September 2009 subperiod

(kg)

Thailand

09.4112

— (2)

0

United States of America

09.4116

— (2)

0

India

09.4117

— (2)

40 445

Pakistan

09.4118

— (2)

0

Other origins

09.4119

— (2)

0

All countries

09.4166

1,04385 %

0

---

(1)  Applications cover quantities less than or equal to the quantities available: all applications are therefore acceptable

(2)  No remaining quantity available for this subperiod

(3)  No application of the allocation coefficient for this subperiod: no licence applications were notified to the Commission.

---

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

DECISIONS

Commission

| 25.7.2009 | EN | Official Journal of the European Union | L 194/56 |
| --- | --- | --- | --- |

25.7.2009

EN

Official Journal of the European Union

L 194/56

---

COMMISSION DECISION

of 22 July 2009

approving certain amended programmes for the eradication and monitoring of animal diseases and zoonoses for the year 2009 and amending Decision 2008/897/EC as regards the Community’s financial contribution to certain Member States for programmes approved by that Decision

(notified under document number C(2009) 5475)

(2009/560/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (1), and in particular Article 24(5) and (6) and Article 25(1) and (2) thereof,

Whereas:

| (1) | Decision 90/424/EEC lays down the procedures governing the Community’s financial contribution for programmes for the eradication, control and monitoring of animal diseases and zoonoses. |
| --- | --- |

(1)

Decision 90/424/EEC lays down the procedures governing the Community’s financial contribution for programmes for the eradication, control and monitoring of animal diseases and zoonoses.

| (2) | Commission Decision 2008/897/EC of 28 November 2008 approving annual and multi-annual national programmes and the financial contribution from the Community for the eradication, control and monitoring of certain animal diseases and zoonoses presented by the Member States for 2009 and following years (2) approves certain national programmes and sets out the rate and maximum amount of the Community’s financial contribution for each programme submitted by the Member States. |
| --- | --- |

(2)

Commission Decision 2008/897/EC of 28 November 2008 approving annual and multi-annual national programmes and the financial contribution from the Community for the eradication, control and monitoring of certain animal diseases and zoonoses presented by the Member States for 2009 and following years (2) approves certain national programmes and sets out the rate and maximum amount of the Community’s financial contribution for each programme submitted by the Member States.

| (3) | Belgium, Denmark, Ireland, Spain, France, Latvia, Lithuania, the Netherlands, Portugal and Finland have submitted amended programmes for the eradication and monitoring of bluetongue. |
| --- | --- |

(3)

Belgium, Denmark, Ireland, Spain, France, Latvia, Lithuania, the Netherlands, Portugal and Finland have submitted amended programmes for the eradication and monitoring of bluetongue.

| (4) | The Commission has assessed those amended programmes from both the veterinary and the financial point of view. Those programmes were found to comply with relevant Community veterinary legislation and in particular with the criteria set out in Commission Decision 2008/341/EC of 25 April 2008 laying down Community criteria for national programmes for the eradication, control and monitoring of certain animal diseases and zoonoses (3). Those amended programmes should therefore be approved. |
| --- | --- |

(4)

The Commission has assessed those amended programmes from both the veterinary and the financial point of view. Those programmes were found to comply with relevant Community veterinary legislation and in particular with the criteria set out in Commission Decision 2008/341/EC of 25 April 2008 laying down Community criteria for national programmes for the eradication, control and monitoring of certain animal diseases and zoonoses (3). Those amended programmes should therefore be approved.

| (5) | Denmark, Spain, Italy, Luxembourg, the Netherlands, Portugal, Finland and the United Kingdom have submitted amended programmes for the monitoring of transmissible spongiform encephalopathies (TSE). |
| --- | --- |

(5)

Denmark, Spain, Italy, Luxembourg, the Netherlands, Portugal, Finland and the United Kingdom have submitted amended programmes for the monitoring of transmissible spongiform encephalopathies (TSE).

| (6) | The Commission has assessed those amended programmes from both the veterinary and the financial point of view. Those programmes were found to comply with relevant Community veterinary legislation and in particular with the criteria set out in Decision 2008/341/EC. Those amended programmes should therefore be approved. |
| --- | --- |

(6)

The Commission has assessed those amended programmes from both the veterinary and the financial point of view. Those programmes were found to comply with relevant Community veterinary legislation and in particular with the criteria set out in Decision 2008/341/EC. Those amended programmes should therefore be approved.

| (7) | A multi-annual programme for the eradication of rabies was approved for Slovenia by Commission Decision 2007/782/EC of 30 November 2007 approving annual and multi-annual national programmes and the financial contribution from the Community for the eradication, control and monitoring of certain animal diseases and zoonoses, presented by the Member States for 2008 and following years (4). The second year of that programme was approved by Decision 2008/897/EC. |
| --- | --- |

(7)

A multi-annual programme for the eradication of rabies was approved for Slovenia by Commission Decision 2007/782/EC of 30 November 2007 approving annual and multi-annual national programmes and the financial contribution from the Community for the eradication, control and monitoring of certain animal diseases and zoonoses, presented by the Member States for 2008 and following years (4). The second year of that programme was approved by Decision 2008/897/EC.

| (8) | Slovenia has submitted an amended version of the programme for the second year of its multi-annual programme for the eradication of rabies. The Commission has assessed that amended programme from both the veterinary and the financial point of view. That programme was found to comply with relevant Community veterinary legislation and in particular with the criteria set out in Decision 2008/341/EC. That amended programme should therefore be approved. |
| --- | --- |

(8)

Slovenia has submitted an amended version of the programme for the second year of its multi-annual programme for the eradication of rabies. The Commission has assessed that amended programme from both the veterinary and the financial point of view. That programme was found to comply with relevant Community veterinary legislation and in particular with the criteria set out in Decision 2008/341/EC. That amended programme should therefore be approved.

| (9) | The national programmes for the eradication and monitoring of bluetongue approved by Decision 2008/897/EC included the vaccination campaigns against that disease in 2009. However, the costs of vaccine administration were not included in the costs eligible for a financial contribution by the Community. |
| --- | --- |

(9)

The national programmes for the eradication and monitoring of bluetongue approved by Decision 2008/897/EC included the vaccination campaigns against that disease in 2009. However, the costs of vaccine administration were not included in the costs eligible for a financial contribution by the Community.

| (10) | In view of the epidemiological situation in the Member States concerned, it is appropriate to include the costs of the vaccine administration in the costs eligible for a financial contribution by the Community. Consequently, it is appropriate to allocate additional funds for the financing of the programmes for the eradication and monitoring of bluetongue in those Member States, approved by Decision 2008/897/EC. |
| --- | --- |

(10)

In view of the epidemiological situation in the Member States concerned, it is appropriate to include the costs of the vaccine administration in the costs eligible for a financial contribution by the Community. Consequently, it is appropriate to allocate additional funds for the financing of the programmes for the eradication and monitoring of bluetongue in those Member States, approved by Decision 2008/897/EC.

| (11) | Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (5), as recently amended by Commission Regulation (EC) No 103/2009 (6), provides for more stringent requirements to be complied with in the case of milk producing flocks infected with classical scrapie. |
| --- | --- |

(11)

Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies (5), as recently amended by Commission Regulation (EC) No 103/2009 (6), provides for more stringent requirements to be complied with in the case of milk producing flocks infected with classical scrapie.

| (12) | On 18 March 2009 Cyprus has submitted a new, multi-annual, programme for the monitoring and eradication of scrapie, adapted to that recent amendment of Regulation (EC) No 999/2001. That programme is to replace the national programme for the eradication of scrapie in that Member State for 2009, approved by Decision 2008/897/EC. |
| --- | --- |

(12)

On 18 March 2009 Cyprus has submitted a new, multi-annual, programme for the monitoring and eradication of scrapie, adapted to that recent amendment of Regulation (EC) No 999/2001. That programme is to replace the national programme for the eradication of scrapie in that Member State for 2009, approved by Decision 2008/897/EC.

| (13) | In view of this exceptional situation, Cyprus requested in the programme to obtain a financial participation above 50 % of the costs incurred in slaughtering animals infected with scrapie. The Commission has assessed that programme from both the veterinary and the financial point of view. That programme was found to comply with relevant Community veterinary legislation and in particular with the criteria set out in Decision 2008/341/EC. That programme should therefore be approved. |
| --- | --- |

(13)

In view of this exceptional situation, Cyprus requested in the programme to obtain a financial participation above 50 % of the costs incurred in slaughtering animals infected with scrapie. The Commission has assessed that programme from both the veterinary and the financial point of view. That programme was found to comply with relevant Community veterinary legislation and in particular with the criteria set out in Decision 2008/341/EC. That programme should therefore be approved.

| (14) | Due to the fact that a very high proportion of the ovine and caprine flocks in Cyprus are infected with scrapie, Cyprus is obliged to cull an exceptionally high number of animals in a short period of time, in order to comply with the requirements of the relevant Community legislation. |
| --- | --- |

(14)

Due to the fact that a very high proportion of the ovine and caprine flocks in Cyprus are infected with scrapie, Cyprus is obliged to cull an exceptionally high number of animals in a short period of time, in order to comply with the requirements of the relevant Community legislation.

| (15) | In view of this exceptional situation, it is appropriate to provide for a higher level of Community contribution to the programme for the monitoring and eradication of scrapie in that Member State. In addition, the cost of personnel specifically hired for carrying out tasks within the programme and the cost of destroying the carcasses should be included in the costs eligible for a Community financial contribution under that programme. |
| --- | --- |

(15)

In view of this exceptional situation, it is appropriate to provide for a higher level of Community contribution to the programme for the monitoring and eradication of scrapie in that Member State. In addition, the cost of personnel specifically hired for carrying out tasks within the programme and the cost of destroying the carcasses should be included in the costs eligible for a Community financial contribution under that programme.

| (16) | The approval of the amended programmes by this Decision has an impact on the amounts needed for carrying out the programmes, as approved under Decision 2008/897/EC. The maximum amount of Community financial contribution for certain programmes should be adjusted accordingly. |
| --- | --- |

(16)

The approval of the amended programmes by this Decision has an impact on the amounts needed for carrying out the programmes, as approved under Decision 2008/897/EC. The maximum amount of Community financial contribution for certain programmes should be adjusted accordingly.

| (17) | Decision 2008/897/EC should therefore be amended accordingly. |
| --- | --- |

(17)

Decision 2008/897/EC should therefore be amended accordingly.

| (18) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(18)

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 amended programmes for the monitoring of and eradication of bluetongue, submitted by Belgium on 29 January 2009, by Denmark on 20 April 2009, by Ireland on 16 February 2009, by Spain on 6 March 2009, by France on 2 February 2009, by Latvia on 20 February 2009, by Lithuania on 20 February 2009, by the Netherlands on 8 December 2008, by Portugal on 20 February 2009 and by Finland on 7 January 2009 are hereby approved for the period from 1 January 2009 to 31 December 2009.

Article 2

The amended programmes for the monitoring of transmissible spongiform encephalopathies submitted by Denmark on 18 March 2009, by Spain on 7 April 2009, by Italy on 29 January 2009, by Luxembourg on 16 March 2009, by the Netherlands on 20 February 2009, by Portugal on 4 March 2009, by Finland on 27 February 2009 and by the United Kingdom on 26 January 2009 are hereby approved for the period from 1 January 2009 to 31 December 2009.

Article 3

The second year of the multi-annual programme for the eradication of rabies, as amended, submitted by Slovenia on 23 April 2009 is hereby approved for the period from 1 January 2009 to 31 December 2009.

Article 4

Decision 2008/897/EC is amended as follows:

| 1. | in Article 4, paragraphs (2) and (3) are replaced by the following:
  ‘2.   The financial contribution by the Community shall be at the rate of 50 % of the costs to be incurred by each Member State referred to in paragraph 1 for the cost of carrying out the vaccination, the laboratory tests for virological, serological and entomological surveillance and the purchase of traps and vaccines and shall not exceed:






  (a) | EUR 4 450 000 for Belgium; |
| --- | --- | --- |

1.

in Article 4, paragraphs (2) and (3) are replaced by the following:

‘2.   The financial contribution by the Community shall be at the rate of 50 % of the costs to be incurred by each Member State referred to in paragraph 1 for the cost of carrying out the vaccination, the laboratory tests for virological, serological and entomological surveillance and the purchase of traps and vaccines and shall not exceed:

(a)

EUR 4 450 000 for Belgium;

| (b) | EUR 5 000 for Bulgaria; |
| --- | --- |

(b)

EUR 5 000 for Bulgaria;

| (c) | EUR 2 350 000 for the Czech Republic; |
| --- | --- |

(c)

EUR 2 350 000 for the Czech Republic;

| (d) | EUR 50 000 for Denmark; |
| --- | --- |

(d)

EUR 50 000 for Denmark;

| (e) | EUR 15 700 000 for Germany; |
| --- | --- |

(e)

EUR 15 700 000 for Germany;

| (f) | EUR 180 000 for Estonia; |
| --- | --- |

(f)

EUR 180 000 for Estonia;

| (g) | EUR 800 000 for Ireland; |
| --- | --- |

(g)

EUR 800 000 for Ireland;

| (h) | EUR 50 000 for Greece; |
| --- | --- |

(h)

EUR 50 000 for Greece;

| (i) | EUR 21 000 000 for Spain; |
| --- | --- |

(i)

EUR 21 000 000 for Spain;

| (j) | EUR 57 000 000 for France; |
| --- | --- |

(j)

EUR 57 000 000 for France;

| (k) | EUR 3 000 000 for Italy; |
| --- | --- |

(k)

EUR 3 000 000 for Italy;

| (l) | EUR 460 000 for Latvia; |
| --- | --- |

(l)

EUR 460 000 for Latvia;

| (m) | EUR 0 for Lithuania; |
| --- | --- |

(m)

EUR 0 for Lithuania;

| (n) | EUR 510 000 for Luxembourg; |
| --- | --- |

(n)

EUR 510 000 for Luxembourg;

| (o) | EUR 1 400 000 for Hungary; |
| --- | --- |

(o)

EUR 1 400 000 for Hungary;

| (p) | EUR 5 000 for Malta; |
| --- | --- |

(p)

EUR 5 000 for Malta;

| (q) | EUR 50 000 for the Netherlands; |
| --- | --- |

(q)

EUR 50 000 for the Netherlands;

| (r) | EUR 3 350 000 for Austria; |
| --- | --- |

(r)

EUR 3 350 000 for Austria;

| (s) | EUR 500 000 for Poland; |
| --- | --- |

(s)

EUR 500 000 for Poland;

| (t) | EUR 5 300 000 for Portugal; |
| --- | --- |

(t)

EUR 5 300 000 for Portugal;

| (u) | EUR 250 000 for Romania; |
| --- | --- |

(u)

EUR 250 000 for Romania;

| (v) | EUR 910 000 for Slovenia; |
| --- | --- |

(v)

EUR 910 000 for Slovenia;

| (w) | EUR 820 000 for Finland; |
| --- | --- |

(w)

EUR 820 000 for Finland;

| (x) | EUR 1 550 000 for Sweden. |
| --- | --- |

(x)

EUR 1 550 000 for Sweden.

3.   The maximum of the costs to be reimbursed to the Member States for the programmes referred to in paragraph 1 shall on average not exceed:

| (a) | for an ELISA test EUR 2,5 per test; |
| --- | --- |

(a)

for an ELISA test EUR 2,5 per test;

| (b) | for a PCR test EUR 10 per test; |
| --- | --- |

(b)

for a PCR test EUR 10 per test;

| (c) | for the purchase of monovalent vaccines EUR 0,3 per dose; |
| --- | --- |

(c)

for the purchase of monovalent vaccines EUR 0,3 per dose;

| (d) | for the purchase of bivalent vaccines EUR 0,45 per dose; |
| --- | --- |

(d)

for the purchase of bivalent vaccines EUR 0,45 per dose;

| (e) | for the administration of vaccines to bovine animals EUR 1,50 per bovine animal vaccinated, regardless of the number and types of doses used; |
| --- | --- |

(e)

for the administration of vaccines to bovine animals EUR 1,50 per bovine animal vaccinated, regardless of the number and types of doses used;

| (f) | for the administration of vaccines to ovine or caprine animals EUR 0,75 per ovine or caprine animal vaccinated, regardless of the number and types of doses used.’; |
| --- | --- |

(f)

for the administration of vaccines to ovine or caprine animals EUR 0,75 per ovine or caprine animal vaccinated, regardless of the number and types of doses used.’;

| 2. | in Article 9(2)(l), the amount ‘EUR 1 800 000’ is replaced by ‘EUR 50 000’; |
| --- | --- |

2.

in Article 9(2)(l), the amount ‘EUR 1 800 000’ is replaced by ‘EUR 50 000’;

| 3. | in Article 13(2)(e), the amount ‘EUR 370 000’ is replaced by ‘EUR 530 000’; |
| --- | --- |

3.

in Article 13(2)(e), the amount ‘EUR 370 000’ is replaced by ‘EUR 530 000’;

| 4. | the following Article 15a is inserted:
  ‘Article 15a
  Scrapie
  1.   The multi-annual programme for the monitoring and eradication of scrapie submitted by Cyprus on 18 March 2009 is hereby approved for the period from 1 January 2009 to 31 December 2010.
  2.   The financial contribution by the Community shall be at the rate of:






  (a) | 100 % of the costs to be incurred by Cyprus for carrying out rapid tests and primary molecular tests; |
| --- | --- | --- |

4.

the following Article 15a is inserted:

‘Article 15a

Scrapie

1.   The multi-annual programme for the monitoring and eradication of scrapie submitted by Cyprus on 18 March 2009 is hereby approved for the period from 1 January 2009 to 31 December 2010.

2.   The financial contribution by the Community shall be at the rate of:

(a)

100 % of the costs to be incurred by Cyprus for carrying out rapid tests and primary molecular tests;

| (b) | 75 % of the cost incurred by Cyprus for the compensation to owners for the value of their animals culled and destroyed in accordance with its programme for monitoring and eradication of scrapie; |
| --- | --- |

(b)

75 % of the cost incurred by Cyprus for the compensation to owners for the value of their animals culled and destroyed in accordance with its programme for monitoring and eradication of scrapie;

| (c) | 50 % of the costs of:






  (i) | the analysis of samples for genotyping; |
| --- | --- | --- |

(c)

50 % of the costs of:

(i)

the analysis of samples for genotyping;

| (ii) | the purchase of preparations used for euthanasing the animals; |
| --- | --- |

(ii)

the purchase of preparations used for euthanasing the animals;

| (iii) | personnel specifically hired for carrying out tasks within the programme; |
| --- | --- |

(iii)

personnel specifically hired for carrying out tasks within the programme;

| (iv) | destruction of the carcasses. |
| --- | --- |

(iv)

destruction of the carcasses.

3.   The maximum of the costs to be reimbursed to Cyprus for the programme referred to in paragraph 1 shall on average not exceed:

| (a) | for tests carried out in ovine and caprine animals referred to in Part II of Chapter A of Annex III to Regulation (EC) No 999/2001 EUR 30 per test; |
| --- | --- |

(a)

for tests carried out in ovine and caprine animals referred to in Part II of Chapter A of Annex III to Regulation (EC) No 999/2001 EUR 30 per test;

| (b) | for primary molecular discriminatory tests carried out as referred to in point 3.2(c)(i) of Chapter C of Annex X to Regulation (EC) No 999/2001 EUR 175 per test; |
| --- | --- |

(b)

for primary molecular discriminatory tests carried out as referred to in point 3.2(c)(i) of Chapter C of Annex X to Regulation (EC) No 999/2001 EUR 175 per test;

| (c) | for genotyping tests EUR 10 per test; |
| --- | --- |

(c)

for genotyping tests EUR 10 per test;

| (d) | for culled sheep or goats 100 EUR per animal. |
| --- | --- |

(d)

for culled sheep or goats 100 EUR per animal.

4.   The amount to be committed for 2009 shall be EUR 5 400 000.

5.   The amount to be committed for the year 2010 shall be decided taking into account the implementation of the programme in 2009.’

Article 5

This Decision is addressed to the Member States.

Done at Brussels, 22 July 2009.

For the Commission

Androulla VASSILIOU

Member of the Commission

---

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

1

(2)  OJ L 322, 2.12.2008, p. 39.

2

(3)  OJ L 115, 29.4.2008, p. 44.

3

(4)  OJ L 314, 1.12.2007, p. 29.

4

(5)  OJ L 147, 31.5.2001, p. 1.

5

(6)  OJ L 34, 4.2.2009, p. 11.

6

---

| 25.7.2009 | EN | Official Journal of the European Union | L 194/60 |
| --- | --- | --- | --- |

25.7.2009

EN

Official Journal of the European Union

L 194/60

---

COMMISSION DECISION

of 22 July 2009

amending Decision 2006/679/EC as regards the implementation of the technical specification for interoperability relating to the control-command and signalling subsystem of the trans-European conventional rail system

(notified under document number C(2009) 5607)

(Text with EEA relevance)

(2009/561/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community (1), and in particular Article 6(1) thereof,

Having regard to the recommendation of the European Railway Agency on the European Deployment Plan (ERA-REC-02-2009-ERTMS) of 23 February 2009,

Whereas:

| (1) | Each technical specifications for interoperability (TSI) should indicate the strategy for implementing the TSIs and the stages to be completed in order to make a gradual transition from the existing situation to the final situation in which compliance with the TSIs shall be the norm. |
| --- | --- |

(1)

Each technical specifications for interoperability (TSI) should indicate the strategy for implementing the TSIs and the stages to be completed in order to make a gradual transition from the existing situation to the final situation in which compliance with the TSIs shall be the norm.

| (2) | Commission Decision 2006/679/EC of 28 March 2006 concerning the technical specification for interoperability relating to the control-command and signalling subsystem of the trans-European conventional rail system (2) laid down the TSI relating to the control-command and signalling subsystem of the trans-European conventional rail system. |
| --- | --- |

(2)

Commission Decision 2006/679/EC of 28 March 2006 concerning the technical specification for interoperability relating to the control-command and signalling subsystem of the trans-European conventional rail system (2) laid down the TSI relating to the control-command and signalling subsystem of the trans-European conventional rail system.

| (3) | In accordance with Article 3 of Decision 2006/679/EC, Member States have established a national implementation plan of the Control Command and Signalling TSI and have notified this implementation plan to the Commission. |
| --- | --- |

(3)

In accordance with Article 3 of Decision 2006/679/EC, Member States have established a national implementation plan of the Control Command and Signalling TSI and have notified this implementation plan to the Commission.

| (4) | On the basis of these national plans the EU Master Plan should be drafted following the principles set out in Chapter 7 of the Annex to Decision 2006/679/EC. |
| --- | --- |

(4)

On the basis of these national plans the EU Master Plan should be drafted following the principles set out in Chapter 7 of the Annex to Decision 2006/679/EC.

| (5) | Chapter 7 of the Annex to Decision 2006/679/EC provides that the EU Master Plan will be appended to the TSI through a revision procedure and will be referred to as the European Deployment Plan. |
| --- | --- |

(5)

Chapter 7 of the Annex to Decision 2006/679/EC provides that the EU Master Plan will be appended to the TSI through a revision procedure and will be referred to as the European Deployment Plan.

| (6) | Directive 2008/57/EC indicates that TSIs may establish the framework necessary to decide whether the existing subsystem may need to be re-authorised, and the corresponding deadlines. |
| --- | --- |

(6)

Directive 2008/57/EC indicates that TSIs may establish the framework necessary to decide whether the existing subsystem may need to be re-authorised, and the corresponding deadlines.

| (7) | The strategy to implement the Control Command and Signalling TSI should not only rely on compliance of subsystems with the TSI at the time of their placing into service, upgrading or renewal but it should also be based on a coordinated implementation along pan-European corridors linking the main European freight transport areas. As interoperability can only be achieved if the corridors are fully equipped, appropriate deadlines for the renewal or upgrading of the subsystem should be set within a European Deployment Plan. |
| --- | --- |

(7)

The strategy to implement the Control Command and Signalling TSI should not only rely on compliance of subsystems with the TSI at the time of their placing into service, upgrading or renewal but it should also be based on a coordinated implementation along pan-European corridors linking the main European freight transport areas. As interoperability can only be achieved if the corridors are fully equipped, appropriate deadlines for the renewal or upgrading of the subsystem should be set within a European Deployment Plan.

| (8) | Member States should make every effort to make available an external Specific Transmission Module for their legacy Class B systems listed in Annex B of the TSI. |
| --- | --- |

(8)

Member States should make every effort to make available an external Specific Transmission Module for their legacy Class B systems listed in Annex B of the TSI.

| (9) | Projects for the European Rail Traffic Management System (ERTMS), in general, and lines included in the European Deployment Plan, in particular, may benefit from Community support from the TEN-T programme or from other programmes of Community financial aid. |
| --- | --- |

(9)

Projects for the European Rail Traffic Management System (ERTMS), in general, and lines included in the European Deployment Plan, in particular, may benefit from Community support from the TEN-T programme or from other programmes of Community financial aid.

| (10) | Adequate financial support is instrumental to ensure the deployment of ERTMS in accordance with the scope and deadlines set by the European Deployment Plan. The plan may therefore be adjusted in order to take account of available funding. |
| --- | --- |

(10)

Adequate financial support is instrumental to ensure the deployment of ERTMS in accordance with the scope and deadlines set by the European Deployment Plan. The plan may therefore be adjusted in order to take account of available funding.

| (11) | The suppliers of ERTMS on-board equipment have confirmed that they will be in a position to deliver on-board equipment compliant with the new standard (known as baseline 3) at the latest by 2015; therefore, international locomotives delivered by that date, should, as a general rule, be equipped with ERTMS. |
| --- | --- |

(11)

The suppliers of ERTMS on-board equipment have confirmed that they will be in a position to deliver on-board equipment compliant with the new standard (known as baseline 3) at the latest by 2015; therefore, international locomotives delivered by that date, should, as a general rule, be equipped with ERTMS.

| (12) | Decision 2006/679/EC should therefore be amended accordingly. |
| --- | --- |

(12)

Decision 2006/679/EC should therefore be amended accordingly.

| (13) | The measures provided for in this Decision are in accordance with the opinion of the Railway Interoperability and Safety Committee, established in accordance with Article 29 of Directive 2008/57/EC, |
| --- | --- |

(13)

The measures provided for in this Decision are in accordance with the opinion of the Railway Interoperability and Safety Committee, established in accordance with Article 29 of Directive 2008/57/EC,

HAS ADOPTED THIS DECISION:

Article 1

The Annex to Decision 2006/679/EC is amended as follows:

| 1. | Sections 7.1, 7.2 and 7.3 are replaced by the text set out in the Annex to this Decision. |
| --- | --- |

1.

Sections 7.1, 7.2 and 7.3 are replaced by the text set out in the Annex to this Decision.

| 2. | In section 7.4.2.3 the reference to section 7.2.2.5 is replaced by a reference to section 7.2. |
| --- | --- |

2.

In section 7.4.2.3 the reference to section 7.2.2.5 is replaced by a reference to section 7.2.

Article 2

By 31 December 2015, the Commission shall evaluate the implementation of the European Deployment Plan and determine, upon analysis of the progress made in its implementation until 2015, the availability of equipment compliant with the new standard (baseline 3) and of the sources and level of funding available to support ERTMS deployment, if amendments to this Decision are necessary, in particular as regards the lines due to be equipped by 2020. The Member States shall be involved in this analysis.

Article 3

This Decision shall apply from 1 September 2009.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 22 July 2009.

For the Commission

Antonio TAJANI

Vice-President

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(1)  OJ L 191, 18.7.2008, p. 1.

1

(2)  OJ L 284, 16.10.2006, p. 1

2

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ANNEX

Sections 7.1, 7.2 and 7.3 of the Annex to Decision 2006/679/EC are replaced by the following:

"7.   IMPLEMENTATION OF THE TSI CONTROL COMMAND

This chapter outlines the strategy for the implementation (ERTMS European Deployment Plan) of the TSI and specifies the stages to be completed in order to make a gradual transition from the existing situation to the final situation in which compliance with the TSIs shall be the norm.

The ERTMS European Deployment Plan does not apply to lines located in the territory of a Member State when its rail network is separated or isolated by the sea or separated as a result of special geographical conditions from the rail network of the rest of the Community. This strategy does not apply to locomotives running exclusively on such lines.

7.1.   
  ERTMS-Trackside implementation

The objective of the ERTMS European Deployment Plan is to ensure that, gradually, locomotives, railcars and other railway vehicles equipped with ERTMS can have access to an increased number of lines, ports, terminals and marshalling yards without needing national equipment in addition to ERTMS.

To that purpose, the deployment plan does not request the removal of the existing Class B systems on the lines included in the plan. However, by the date specified in the implementation plan, equipment with a Class B system shall not be a track access condition to lines included in the deployment plan for locomotives, railcars and other railway vehicles equipped with ERTMS.

When terminal areas, such as ports or specific lines in a port for example, are not equipped with any Class B system, the requirements related to the “connection” of these terminal areas does not necessarily mean that these terminals or lines need to be equipped with ERTMS, as long as equipment with a Class B system is not requested as a track access condition.

For lines consisting of a double track or more, the line is considered to be equipped as soon as a double track is equipped. When there is more than one line on a corridor section, at least one line has to be equipped on the section and the whole corridor is considered to be equipped as soon as at least one line is equipped on the whole length of the corridor.

7.1.1.   Corridors

The six corridors described in Appendix I shall be equipped with ERTMS according to the timetable indicated in that Appendix (1).

7.1.2.   Connection to the main European ports, marshalling yards, freight terminals and freight transport areas

The ports, marshalling yards, freight terminals and freight transport areas listed in Appendix II shall be linked to at least one of the six corridors specified in Appendix I at the date and under the conditions specified in Appendix II.

7.1.3.   EU-funded projects

Without prejudice to sections 7.1.1 and 7.1.2 the fitting of ERTMS/ETCS is mandatory in the case of:

| — | new installations of the train protection part of a CCS assembly or, |
| --- | --- |

—

new installations of the train protection part of a CCS assembly or,

| — | an upgrade of the train protection part of a CCS assembly already in service that changes the functions or the performance of the subsystem, |
| --- | --- |

—

an upgrade of the train protection part of a CCS assembly already in service that changes the functions or the performance of the subsystem,

for railway infrastructure projects receiving financial support from European Regional Development Funds and/or Cohesion Funds (Council Regulation (EC) No 1083/2006 (2)) and/or the TEN-T funds (Decision No 1692/96/EC of the European Parliament and of the Council (3)).

However, when signalling is renewed on short (less than 150 km) and discontinuous sections of a line, the Commission may grant derogation to this rule, provided ERTMS is installed before the earliest of these two dates:

| — | 5 years after the end of the project; |
| --- | --- |

—

5 years after the end of the project;

| — | the time by which the section of the line is connected to another ERTMS equipped line, |
| --- | --- |

—

the time by which the section of the line is connected to another ERTMS equipped line,

In this section, the earliest of these two dates is called “later date for equipment”.

The Member State concerned shall forward a file to the Commission. This file shall contain an economical analysis showing that there is a substantial economical and/or technical advantage in putting ERTMS into service at the later date for equipment rather than during the course of the EU-funded project.

Such clause can only be advocated by a Member State when the tender covering the renewal or upgrade of the train protection system contains a clear option for the ERTMS equipment of the line, either in the course of the project or at the later date for equipment.

The Commission shall analyse the file submitted and the measures proposed by the Member State and shall inform the committee referred to in Article 29 of Directive 2008/57/EC of the European Parliament and of the Council (4) of the result of its analysis. When a derogation is granted, the Member State shall ensure that ERTMS is installed before the later date for equipment.

7.1.4.   Conditions under which optional functions are required

According to the characteristics of the trackside Control-Command Trackside Assembly and its interfaces with other sub-systems, some trackside functionalities not classified as mandatory, may have necessarily to be implemented in certain applications to comply with the essential requirements.

The trackside implementation of National or Optional-functions must not prevent the entry onto that infrastructure of a train that complies only with the mandatory requirements of Onboard Class A system except as required for the following on-board optional functions:

| — | an ETCS Level 3 Trackside application requires train integrity supervision onboard; |
| --- | --- |

—

an ETCS Level 3 Trackside application requires train integrity supervision onboard;

| — | an ETCS Level 1 Trackside application with infill requires corresponding in-fill functionality onboard if the release speed is set to zero for safety reasons (e.g., protection of danger points); |
| --- | --- |

—

an ETCS Level 1 Trackside application with infill requires corresponding in-fill functionality onboard if the release speed is set to zero for safety reasons (e.g., protection of danger points);

| — | when ETCS requires data transmission by radio, the data transmission services of GSM-R must fulfil the ETCS data transmission requirements; |
| --- | --- |

—

when ETCS requires data transmission by radio, the data transmission services of GSM-R must fulfil the ETCS data transmission requirements;

| — | an onboard assembly, which incorporates a KER STM, may require to implement the K-interface. |
| --- | --- |

—

an onboard assembly, which incorporates a KER STM, may require to implement the K-interface.

7.1.5.   Legacy systems

Member States shall ensure that the functionality of the legacy systems referred to in Annex B to the TSI as well as their interfaces is to remain as currently specified, excluding those modifications that might be deemed necessary in order to mitigate safety-related flaws of these systems. Member States shall make available the necessary information regarding their legacy systems that is required for the purposes of development and certification of apparatus allowing interoperability of Class A equipment with their legacy Class B facilities.

7.1.6.   Notification

For each corridor section described in Appendix I, Member States shall either notify to the Commission a detailed timeline for the equipment with ERTMS of the corridor section or confirm that the corridor section is already equipped. The information shall be notified to the Commission at the latest three years before the latest equipment date of the corridor section specified in Appendix I.

For each port, marshalling yard, freight terminal or freight transport area listed in Appendix II, Member States shall notify the specific lines to be used to ensure its connection with one of the corridors listed in Appendix I. This information shall be notified to the Commission at the latest three years before the date specified in Appendix II and shall indicate the latest equipment date for this port, marshalling yard, freight terminal or freight transport area. As necessary, the European Commission may request adjustments, in particular in order to ensure consistency between equipped lines at the borders. Member States shall either notify to the Commission a detailed timeline for the equipment with ERTMS of these specific lines or confirm that these specific lines are already equipped with ERTMS. This information shall be notified to the Commission at the latest three years before the date specified in Appendix II and shall indicate the latest equipment date for this port, marshalling yard, freight terminal or freight transport area.

The detailed timelines shall in particular indicate the date by which the tender for the equipment of the line will be concluded, the procedures put in place in order to ensure interoperability with the neighbouring countries on the corridor as well as the main milestones related to the project. Member States shall notify the Commission every twelve months on the progress made with the implementation on these lines by sending an updated timeline.

7.1.7.   Delays

When a Member State reasonably expects delays in fulfilling the deadlines laid down in the present Decision, it shall immediately inform the Commission. It shall communicate to the Commission a file containing a technical description of the project and an up to date planning. The file shall also explain the reasons for the delay and shall indicate the corrective measures put in place by the Member State.

An additional delay of no more than three years can be granted to a Member State when the delay is caused by causes beyond Member State’s reasonable control such as failure of suppliers or problems regarding the homologation and approval process due to the absence of appropriate test vehicles. Such clause can only be advocated by a Member State when the following conditions are fulfilled:

| — | the notifications referred in section 7.1.6 were received in time and were comprehensive; |
| --- | --- |

—

the notifications referred in section 7.1.6 were received in time and were comprehensive;

| — | the file referred to in section 7.1.7 first paragraph, contains clear evidence that the causes for the delay were beyond Member State’s control; |
| --- | --- |

—

the file referred to in section 7.1.7 first paragraph, contains clear evidence that the causes for the delay were beyond Member State’s control;

| — | a competent authority is responsible for the coordination, of on-board and trackside suppliers and integration and testing of products; |
| --- | --- |

—

a competent authority is responsible for the coordination, of on-board and trackside suppliers and integration and testing of products;

| — | appropriate use of existing laboratories has been made; |
| --- | --- |

—

appropriate use of existing laboratories has been made;

| — | evidence is given that appropriate measures have been implemented to minimise the additional delay. |
| --- | --- |

—

evidence is given that appropriate measures have been implemented to minimise the additional delay.

The Commission shall analyse the file submitted and the measures proposed by the Member State and shall inform the committee referred to in Article 29 of Directive 2008/57/EC of the result of its analysis.

7.2.   
  ETCS On-board implementation

New locomotives, new railcars and other new railway vehicles able to run without traction equipped with a driving cab, ordered after 1 January 2012 or put into service after 1 January 2015, shall be equipped with ERTMS.

This requirement does not apply to new shunting locomotives and to other new locomotives, new railcars and other new railway vehicles equipped with a driving cab, if they are designed exclusively for national service or regional border crossing service. Member States may however introduce additional requirements at national level, in particular with a view to:

| — | restrict the access to ERTMS equipped lines to ERTMS equipped locomotives, so that existing national systems can be decommissioned, |
| --- | --- |

—

restrict the access to ERTMS equipped lines to ERTMS equipped locomotives, so that existing national systems can be decommissioned,

| — | request that new shunting locomotives and/or other new railway vehicles equipped with a driving cab, even designed exclusively for national service or regional border crossing service, are equipped with ERTMS, |
| --- | --- |

—

request that new shunting locomotives and/or other new railway vehicles equipped with a driving cab, even designed exclusively for national service or regional border crossing service, are equipped with ERTMS,

7.3.   
  GSM-R specific implementation rules

These rules apply in addition to the rules laid down in section 7.1 and 7.2.

7.3.1.   Trackside installations

The fitting of GSM-R is mandatory in the case of:

| — | new installations of the radio part of a CCS assembly; |
| --- | --- |

—

new installations of the radio part of a CCS assembly;

| — | an upgrade of the radio part of a CCS assembly already in service that changes the functions or the performance of the subsystem. |
| --- | --- |

—

an upgrade of the radio part of a CCS assembly already in service that changes the functions or the performance of the subsystem.

7.3.2.   On-board installations

The fitting of GSM-R in rolling stock intended for use on a line including at least a section equipped with Class A interfaces (even if superimposed to a Class B system), is mandatory in the case of:

| — | new installations of the radio part of a CCS assembly; |
| --- | --- |

—

new installations of the radio part of a CCS assembly;

| — | an upgrade of the radio part of a CCS assembly already in service that changes the functions or the performance of the subsystem. |
| --- | --- |

—

an upgrade of the radio part of a CCS assembly already in service that changes the functions or the performance of the subsystem.

7.3.3.   Legacy systems

Member States shall ensure that the functionality of the legacy systems referred to in Annex B to the TSI as well as their interfaces is to remain as currently specified, excluding those modifications that might be deemed necessary in order to mitigate safety-related flaws of these systems. Member States shall make available the necessary information regarding their legacy systems that is required for purposes of development and certification of apparatus allowing interoperability of Class A equipment with their legacy Class B facilities.

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(1)  Appendix I indicates the latest date for equipment, with a view to build a consistent ERTMS network on a step by step basis. In a number of cases, voluntary agreements as regards an earlier equipment date exist.

1

(2)  OJ L 210, 31.7.2006, p. 25.

2

(3)  OJ L 228, 9.9.1996, p. 1.

3

(4)  OJ L 191, 18.7.2008, p. 1.

4

Appendix I

specific lines constituting the corridors

Corridor A – to be equipped by 2015

Image

Corridor B (1)

Image

Corridor C (2)

Image

Corridor D (3)

Image

Corridor E

Image

Corridor F

Image

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(1)  Without prejudice of the legislation applicable to the Trans European high speed network, links can be provided through stretches of high speed lines, provided paths are allocated to freight trains. At least one ERTMS equipped link will be provided by 2020 between Denmark and Germany (Flensburg-Hamburg or Rødby – Puttgarden) but not necessarily two. The Brenner base tunnel will be equipped with ERTMS once the infrastructure work completed (target date 2020).

(2)  A link between Nancy and Reding will be provided by 2020.

(3)  Two additional branches will be equipped by 2020: Montmélian – Grenoble – Valence and Lyon – Valence – Arles – Miramas (left side of the Rhône).

Appendix II

main European ports, marshalling yards, freight terminals and freight transport areas
   (1)

| Country | Freight transport area | Date | Remark |
| --- | --- | --- | --- |
| Belgium | Antwerpen | 31.12.2015 | A link to Rotterdam shall also be provided by 2020. |
| Gent | 31.12.2020 | |
| Zeebrugge | 31.12.2020 | |
| Bulgaria | Burgas | 31.12.2020 | The connection to corridor E implies the equipment of the section Bourgas-Sofia and Sofia-Vidin-Calafat and Calafat-Curtici in Romania (PP22). |
| Czech Republic | Praha | 31.12.2015 | |
| Lovosice | 31.12.2020 | |
| Denmark | Taulov | 31.12.2020 | Connecting this terminal implies that the Flensburg-Padborg line is chosen to be an ERTMS equipped link — see footnote 1 of Appendix I of the Annex. |
| Germany | Dresden (2) | 31.12.2020 | By 2020, a direct link between corridor E and corridor F (from Dresden to Hannover) shall also be ensured. |
| Lübeck | 31.12.2020 | |
| Duisburg | 31.12.2015 | |
| Hamburg (3) | 31.12.2020 | |
| Köln | 31.12.2015 | |
| München | 31.12.2015 | |
| Hannover | 31.12.2015 | |
| Rostock | 31.12.2015 | |
| Ludwigshafen/Mannheim | 31.12.2015 | |
| Nürnberg | 31.12.2020 | |
| Greece | Pireás | 31.12.2020 | The connection to Corridor E implies equipment of the section Kulata-Sofia in Bulgaria. |
| Spain | Algeciras | 31.12.2020 | |
| Madrid | 31.12.2020 | |
| Pamplona | 31.12.2020 | Three connections are requested. A connection to Paris via Hendaye, a connection from Pamplona to Madrid and a connection from Pamplona to corridor D via Zaragoza. |
| Zaragoza | 31.12.2020 | |
| Tarragona | 31.12.2020 | |
| Barcelona | 31.12.2015 | |
| Valencia | 31.12.2020 | |
| France | Marseille | 31.12.2020 | |
| Perpignan | 31.12.2015 | |
| Avignon | 31.12.2015 | |
| Lyon | 31.12.2015 | |
| Le Havre | 31.12.2020 | |
| Lille | 31.12.2020 | |
| Dunkerque | 31.12.2020 | |
| Paris | 31.12.2020 | By 2020 the following connections will be provided: (i) Hendaye (ii) Channel Tunnel (iii) Dijon (iv) Metz via Epernay and Châlons-en-Champagne. |
| Italy | La Spezia | 31.12.2020 | |
| Genova | 31.12.2015 | |
| Gioia Tauro | 31.12.2020 | |
| Verona | 31.12.2015 | |
| Milano | 31.12.2015 | |
| Taranto | 31.12.2020 | |
| Bari | 31.12.2020 | |
| Padova | 31.12.2015 | |
| Trieste | 31.12.2015 | |
| Novara | 31.12.2015 | |
| Bologna | 31.12.2020 | |
| Roma | 31.12.2020 | |
| Luxembourg | Bettembourg | 31.12.2015 | |
| Hungary | Budapest | 31.12.2015 | |
| Netherlands | Amsterdam | 31.12.2020 | |
| Rotterdam | 31.12.2015 | A link to Antwerp shall also be provided by 2020. |
| Austria | Graz | 31.12.2020 | |
| Wien | 31.12.2020 | |
| Poland | Gdynia | 31.12.2015 | |
| Katowice | 31.12.2020 | |
| Wrocław | 31.12.2015 | By 2020 the line Wroclaw-Legnica, shall be equipped in order to ensure a direct link to the German border (Gorlitz). |
| Gliwice | 31.12.2015 | |
| Poznań | 31.12.2015 | |
| Warszawa | 31.12.2015 | |
| Portugal | Sines | 31.12.2020 | |
| Lisboa | 31.12.2020 | |
| Romania | Constanța | 31.12.2015 | |
| Slovenia | Koper | 31.12.2015 | |
| Ljubljana | 31.12.2015 | |
| Slovakia | Bratislava | 31.12.2015 | |
| UK | Bristol | This terminal will be connected as corridor C is extended to the Channel Tunnel. |

Country

Freight transport area

Date

Remark

Belgium

Antwerpen

31.12.2015

A link to Rotterdam shall also be provided by 2020.

Gent

31.12.2020

Zeebrugge

31.12.2020

Bulgaria

Burgas

31.12.2020

The connection to corridor E implies the equipment of the section Bourgas-Sofia and Sofia-Vidin-Calafat and Calafat-Curtici in Romania (PP22).

Czech Republic

Praha

31.12.2015

Lovosice

31.12.2020

Denmark

Taulov

31.12.2020

Connecting this terminal implies that the Flensburg-Padborg line is chosen to be an ERTMS equipped link — see footnote 1 of Appendix I of the Annex.

Germany

Dresden (2)

31.12.2020

By 2020, a direct link between corridor E and corridor F (from Dresden to Hannover) shall also be ensured.

Lübeck

31.12.2020

Duisburg

31.12.2015

Hamburg (3)

31.12.2020

Köln

31.12.2015

München

31.12.2015

Hannover

31.12.2015

Rostock

31.12.2015

Ludwigshafen/Mannheim

31.12.2015

Nürnberg

31.12.2020

Greece

Pireás

31.12.2020

The connection to Corridor E implies equipment of the section Kulata-Sofia in Bulgaria.

Spain

Algeciras

31.12.2020

Madrid

31.12.2020

Pamplona

31.12.2020

Three connections are requested. A connection to Paris via Hendaye, a connection from Pamplona to Madrid and a connection from Pamplona to corridor D via Zaragoza.

Zaragoza

31.12.2020

Tarragona

31.12.2020

Barcelona

31.12.2015

Valencia

31.12.2020

France

Marseille

31.12.2020

Perpignan

31.12.2015

Avignon

31.12.2015

Lyon

31.12.2015

Le Havre

31.12.2020

Lille

31.12.2020

Dunkerque

31.12.2020

Paris

31.12.2020

By 2020 the following connections will be provided: (i) Hendaye (ii) Channel Tunnel (iii) Dijon (iv) Metz via Epernay and Châlons-en-Champagne.

Italy

La Spezia

31.12.2020

Genova

31.12.2015

Gioia Tauro

31.12.2020

Verona

31.12.2015

Milano

31.12.2015

Taranto

31.12.2020

Bari

31.12.2020

Padova

31.12.2015

Trieste

31.12.2015

Novara

31.12.2015

Bologna

31.12.2020

Roma

31.12.2020

Luxembourg

Bettembourg

31.12.2015

Hungary

Budapest

31.12.2015

Netherlands

Amsterdam

31.12.2020

Rotterdam

31.12.2015

A link to Antwerp shall also be provided by 2020.

Austria

Graz

31.12.2020

Wien

31.12.2020

Poland

Gdynia

31.12.2015

Katowice

31.12.2020

Wrocław

31.12.2015

By 2020 the line Wroclaw-Legnica, shall be equipped in order to ensure a direct link to the German border (Gorlitz).

Gliwice

31.12.2015

Poznań

31.12.2015

Warszawa

31.12.2015

Portugal

Sines

31.12.2020

Lisboa

31.12.2020

Romania

Constanța

31.12.2015

Slovenia

Koper

31.12.2015

Ljubljana

31.12.2015

Slovakia

Bratislava

31.12.2015

UK

Bristol

This terminal will be connected as corridor C is extended to the Channel Tunnel.

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(1)  The list of hubs included in this Appendix may be revised, as long as any revisions do not reduce freight traffic or significantly impact projects in other Member States."

(2)  Germany will do its best to equip the corridor E section, Dresden-Czech border at an earlier date.

(3)  Germany will ensure the equipment of a rail link to Hamburg but the harbour area may only be partly equipped by 2020.

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