# Official Journal L 80/2010

| | ISSN 1725-2555
  doi:10.3000/17252555.L_2010.080.eng |
| --- | --- |
| Official Journal
  of the European Union | L 80 |
| | |
| English edition | Legislation | Volume 5326 March 2010 |

ISSN 1725-2555

doi:10.3000/17252555.L_2010.080.eng

Official Journal

of the European Union

L 80

English edition

Legislation

Volume 5326 March 2010

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Regulation (EU) No 254/2010 of 10 March 2010 approving a control programme for Salmonella in poultry in certain third countries in accordance with Regulation (EC) No 2160/2003 of the European Parliament and of the Council and amending Annex I to Regulation (EC) No 798/2008 as regards the Salmonella control status of certain third countries (
  1
  ) | 1 |
| | * | Commission Regulation (EU) No 255/2010 of 25 March 2010 laying down common rules on air traffic flow management (
  1
  ) | 10 |
| | * | Commission Regulation (EU) No 256/2010 of 25 March 2010 entering a name in the register of protected designations of origin and protected geographical indications (Alubia de La Bañeza-León (PGI)) | 17 |
| | * | Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives (
  1
  ) | 19 |
| | * | Commission Regulation (EU) No 258/2010 of 25 March 2010 imposing special conditions on the imports of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxins, and repealing Decision 2008/352/EC (
  1
  ) | 28 |
| | * | Commission Regulation (EU) No 259/2010 of 25 March 2010 entering a name in the register of protected designations of origin and protected geographical indications (Colline Pontine (PDO)) | 32 |
| | * | Commission Regulation (EU) No 260/2010 of 25 March 2010 entering a name in the register of protected designations of origin and protected geographical indications (Chirimoya de la Costa tropical de Granada-Málaga (PDO)) | 34 |
| | * | Commission Regulation (EU) No 261/2010 of 25 March 2010 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate | 36 |
| | * | Commission Regulation (EU) No 262/2010 of 24 March 2010 amending for the 122nd time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with Usama bin Laden, the Al-Qaida network and the Taliban | 40 |
| | | Commission Regulation (EU) No 263/2010 of 25 March 2010 establishing the standard import values for determining the entry price of certain fruit and vegetables | 44 |
| | | Commission Regulation (EU) No 264/2010 of 25 March 2010 amending the representative prices and additional import duties for certain products in the sugar sector fixed by Regulation (EC) No 877/2009 for the 2009/10 marketing year | 46 |
| | | DECISIONS |
| | * | Council Decision 2010/179/CFSP of 11 March 2010 in support of SEESAC arms control activities in the Western Balkans, in the framework of the EU Strategy to combat the illicit accumulation and trafficking of SALW and their ammunition | 48 |
| | | 2010/180/EU |
| | * | Commission Decision of 25 March 2010 on amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
  (notified under document C(2010) 1867)

   (
  1
  ) | 52 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Regulation (EU) No 254/2010 of 10 March 2010 approving a control programme for Salmonella in poultry in certain third countries in accordance with Regulation (EC) No 2160/2003 of the European Parliament and of the Council and amending Annex I to Regulation (EC) No 798/2008 as regards the Salmonella control status of certain third countries (
  1
  )

Salmonella

Salmonella

1

1

*

Commission Regulation (EU) No 255/2010 of 25 March 2010 laying down common rules on air traffic flow management (
  1
  )

1

10

*

Commission Regulation (EU) No 256/2010 of 25 March 2010 entering a name in the register of protected designations of origin and protected geographical indications (Alubia de La Bañeza-León (PGI))

17

*

Commission Regulation (EU) No 257/2010 of 25 March 2010 setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives (
  1
  )

1

19

*

Commission Regulation (EU) No 258/2010 of 25 March 2010 imposing special conditions on the imports of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxins, and repealing Decision 2008/352/EC (
  1
  )

1

28

*

Commission Regulation (EU) No 259/2010 of 25 March 2010 entering a name in the register of protected designations of origin and protected geographical indications (Colline Pontine (PDO))

32

*

Commission Regulation (EU) No 260/2010 of 25 March 2010 entering a name in the register of protected designations of origin and protected geographical indications (Chirimoya de la Costa tropical de Granada-Málaga (PDO))

34

*

Commission Regulation (EU) No 261/2010 of 25 March 2010 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate

36

*

Commission Regulation (EU) No 262/2010 of 24 March 2010 amending for the 122nd time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with Usama bin Laden, the Al-Qaida network and the Taliban

40

Commission Regulation (EU) No 263/2010 of 25 March 2010 establishing the standard import values for determining the entry price of certain fruit and vegetables

44

Commission Regulation (EU) No 264/2010 of 25 March 2010 amending the representative prices and additional import duties for certain products in the sugar sector fixed by Regulation (EC) No 877/2009 for the 2009/10 marketing year

46

DECISIONS

*

Council Decision 2010/179/CFSP of 11 March 2010 in support of SEESAC arms control activities in the Western Balkans, in the framework of the EU Strategy to combat the illicit accumulation and trafficking of SALW and their ammunition

48

2010/180/EU

*

Commission Decision of 25 March 2010 on amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
  (notified under document C(2010) 1867)

   (
  1
  )

(notified under document C(2010) 1867)

1

52

| | |
| --- | --- |
| | (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.

---

II Non-legislative acts

REGULATIONS

| 26.3.2010 | EN | Official Journal of the European Union | L 80/1 |
| --- | --- | --- | --- |

26.3.2010

EN

Official Journal of the European Union

L 80/1

---

COMMISSION REGULATION (EU) No 254/2010

of 10 March 2010

approving a control programme for Salmonella in poultry in certain third countries in accordance with Regulation (EC) No 2160/2003 of the European Parliament and of the Council and amending Annex I to Regulation (EC) No 798/2008 as regards the Salmonella control status of certain third countries

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 90/539/EEC of 15 October 1990 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (1), and in particular Article 21(1) thereof,

Having regard to Regulation (EC) No 2160/2003 of the European Parliament and of the Council of 17 November 2003 on the control of Salmonella and other specified food-borne zoonotic agents (2), and in particular Article 10(2) thereof,

Whereas:

| (1) | Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (3) provides that the commodities covered by that Regulation are only to be imported into and transit through the Union from the third countries, territories, zones or compartments listed in Annex I thereto. |
| --- | --- |

(1)

Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (3) provides that the commodities covered by that Regulation are only to be imported into and transit through the Union from the third countries, territories, zones or compartments listed in Annex I thereto.

| (2) | Regulation (EC) No 2160/2003 lays down rules for the control of Salmonella in different poultry populations in the Union. Admission to or retention on the list of third countries provided for in Union legislation from which Member States are authorised to import animals covered by that Regulation is subject to the submission to the Commission by the third country concerned of a control programme for Salmonella with equivalent guarantees as those contained in the national control programmes for Salmonella in the Member States. |
| --- | --- |

(2)

Regulation (EC) No 2160/2003 lays down rules for the control of Salmonella in different poultry populations in the Union. Admission to or retention on the list of third countries provided for in Union legislation from which Member States are authorised to import animals covered by that Regulation is subject to the submission to the Commission by the third country concerned of a control programme for Salmonella with equivalent guarantees as those contained in the national control programmes for Salmonella in the Member States.

| (3) | In accordance with Commission Regulation (EC) No 584/2008 (4), Salmonella control programmes concerning breeding and productive poultry of turkeys, hatching eggs thereof, day-old chicks of turkeys and slaughter poultry and poultry for restocking of turkeys provided for in Regulation (EC) No 2160/2003, are to apply from 1 January 2010 within the Union. |
| --- | --- |

(3)

In accordance with Commission Regulation (EC) No 584/2008 (4), Salmonella control programmes concerning breeding and productive poultry of turkeys, hatching eggs thereof, day-old chicks of turkeys and slaughter poultry and poultry for restocking of turkeys provided for in Regulation (EC) No 2160/2003, are to apply from 1 January 2010 within the Union.

| (4) | Canada, Israel and the United States have submitted to the Commission a control programme for Salmonella in breeding flocks of turkeys, hatching eggs thereof and day-old chicks of turkeys. These programmes provide the guarantees required by Regulation (EC) No 2160/2003 and should therefore be approved. |
| --- | --- |

(4)

Canada, Israel and the United States have submitted to the Commission a control programme for Salmonella in breeding flocks of turkeys, hatching eggs thereof and day-old chicks of turkeys. These programmes provide the guarantees required by Regulation (EC) No 2160/2003 and should therefore be approved.

| (5) | Certain third countries currently listed in Annex I to Regulation (EC) No 798/2008 have not yet submitted any control programme for Salmonella in flocks of turkeys to the Commission, or alternatively the programmes submitted by them do not provide guarantees equivalent to those required by Regulation (EC) No 2160/2003. Imports of breeding and productive poultry of turkeys, hatching eggs thereof, day-old chicks of turkeys and slaughter poultry and poultry for restocking of turkeys should therefore no longer be authorised from those third countries from 1 January 2010. |
| --- | --- |

(5)

Certain third countries currently listed in Annex I to Regulation (EC) No 798/2008 have not yet submitted any control programme for Salmonella in flocks of turkeys to the Commission, or alternatively the programmes submitted by them do not provide guarantees equivalent to those required by Regulation (EC) No 2160/2003. Imports of breeding and productive poultry of turkeys, hatching eggs thereof, day-old chicks of turkeys and slaughter poultry and poultry for restocking of turkeys should therefore no longer be authorised from those third countries from 1 January 2010.

| (6) | Israel has submitted to the Commission a control programme for Salmonella in day-old chicks of Gallus gallus, intended for flocks of laying hens and broilers, supplementing the control programme of Israel approved by Commission Decision 2007/843/EC (5). Control programmes for Salmonella in flocks of breeding hens and hatching eggs thereof and day-old chicks of Gallus gallus were also submitted by Brazil. These programmes provide the guarantees required by Regulation (EC) No 2160/2003 and should therefore be approved. |
| --- | --- |

(6)

Israel has submitted to the Commission a control programme for Salmonella in day-old chicks of Gallus gallus, intended for flocks of laying hens and broilers, supplementing the control programme of Israel approved by Commission Decision 2007/843/EC (5). Control programmes for Salmonella in flocks of breeding hens and hatching eggs thereof and day-old chicks of Gallus gallus were also submitted by Brazil. These programmes provide the guarantees required by Regulation (EC) No 2160/2003 and should therefore be approved.

| (7) | The list of third countries, territories, zones or compartments and the model veterinary certificates for the import of breeding and productive poultry, day old chicks and hatching eggs set out in Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly. |
| --- | --- |

(7)

The list of third countries, territories, zones or compartments and the model veterinary certificates for the import of breeding and productive poultry, day old chicks and hatching eggs set out in Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly.

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

(8)

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

HAS ADOPTED THIS REGULATION:

Article 1

The control programme in accordance with Article 10(1) of Regulation (EC) No 2160/2003 is hereby approved as regards Salmonella:

| (a) | in breeding flocks of turkeys, hatching eggs thereof and day-old chicks of turkeys submitted by Canada, Israel and the United States; |
| --- | --- |

(a)

in breeding flocks of turkeys, hatching eggs thereof and day-old chicks of turkeys submitted by Canada, Israel and the United States;

| (b) | in day-old chicks of Gallus gallus intended for flocks of laying hens or broilers submitted by Israel; |
| --- | --- |

(b)

in day-old chicks of Gallus gallus intended for flocks of laying hens or broilers submitted by Israel;

| (c) | in breeding hens of Gallus gallus, hatching eggs thereof and day-old chicks of Gallus gallus submitted by Brazil. |
| --- | --- |

(c)

in breeding hens of Gallus gallus, hatching eggs thereof and day-old chicks of Gallus gallus submitted by Brazil.

Article 2

Annex I to Regulation (EC) No 798/2008 is amended in accordance with the Annex to this Regulation.

Article 3

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 1 January 2010.

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

Done at Brussels, 10 March 2010.

For the Commission

The President

José Manuel BARROSO

---

(1)  OJ L 303, 31.10.1990, p. 6.

1

(2)  OJ L 325, 12.12.2003, p. 1.

2

(3)  OJ L 226, 23.8.2008, p. 1.

3

(4)  OJ L 162, 21.6.2008, p. 3.

4

(5)  OJ L 332, 18.12.2007, p. 81.

5

---

ANNEX

Annex I to Regulation (EC) No 798/2008 is amended as follows:

| 1. | Part 1 is replaced by the following:
  ‘PART 1

  List of third countries, territories, zones or compartments
















  ISO code and name of third country or territory | Code of third country, territory, zone or compartment | Description of third country, territory, zone or compartment | Veterinary certificate | Specific conditions | Specific conditions | Avian influenza surveillance status | Avian influenza vaccination status | Salmonella control status |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Model(s) | Additional guarantees | Closing date (1) | Opening date (2) |
| 1 | 2 | 3 | 4 | 5 | 6 | 6A | 6B | 7 | 8 | 9 |
| AL — Albania | AL-0 | Whole country | EP, E | | | | | | | S4 |
| AR — Argentina | AR-0 | Whole country | SPF | | | | | | | |
| POU, RAT, EP, E | | | | | A | | S4 |
| WGM | VIII | | | | | | |
| AU — Australia | AU-0 | Whole country | SPF | | | | | | | |
| EP, E | | | | | | | S4 |
| BPP, DOC, HEP, SRP | | | | | | | S0, ST0 |
| BPR | I | | | | | | |
| DOR | II | | | | | | |
| HER | III | | | | | | |
| POU | VI | | | | | | |
| RAT | VII | | | | | | |
| BR — Brazil | BR-0 | Whole country | SPF | | | | | | | |
| BR-1 | States of:
  Rio Grande do Sul, Santa Catarina, Paraná, São Paulo and Mato Grosso do Sul | RAT, BPR, DOR, HER, SRA | | N | | | A | | |
| BR-2 | States of:
  Mato Grosso, Paraná, Rio Grande do Sul, Santa Catarina and São Paulo | BPP, DOC, HEP, SRP | | N | | | | S5, ST0 |
| BR-3 | Distrito Federal and States of:
  Goiás, Minas Gerais, Mato Grosso, Mato Grosso do Sul, Paraná, Rio Grande do Sul, Santa Catarina and São Paulo | WGM | VIII | | | | | | |
| EP, E, POU | | N | | | | | S4 |
| BW — Botswana | BW-0 | Whole country | SPF | | | | | | | |
| EP, E | | | | | | | S4 |
| BPR | I | | | | | | |
| DOR | II | | | | | | |
| HER | III | | | | | | |
| RAT | VII | | | | | | |
| BY — Belarus | BY-0 | Whole country | EP and E (both “only for transit through the EU”) | IX | | | | | | |
| CA — Canada | CA-0 | Whole country | SPF | | | | | | | |
| EP, E | | | | | | | S4 |
| BPR, BPP, DOR, HER, SRA, SRP | | N | | | A | | S1, ST1 |
| DOC, HEP | | L, N | | | |
| WGM | VIII | | | | | | |
| POU, RAT | | N | | | | | |
| CH — Switzerland | CH-0 | Whole country | (3) | | | | | A | | (3) |
| CL — Chile | CL-0 | Whole country | SPF | | | | | | | |
| EP, E | | | | | | | S4 |
| BPR, BPP, DOC, DOR, HEP, HER, SRA, SRP | | N | | | A | | S0, ST0 |
| WGM | VIII | | | | | | |
| POU, RAT | | N | | | | | |
| CN — China | CN-0 | Whole country | EP | | | | | | | |
| CN-1 | Province of Shandong | POU, E | VI | P2 | 6.2.2004 | — | | | S4 |
| GL — Greenland | GL-0 | Whole country | SPF | | | | | | | |
| EP, WGM | | | | | | | |
| HK — Hong Kong | HK-0 | The whole territory of the Hong Kong Special Administrative Region | EP | | | | | | | |
| HR — Croatia | HR-0 | Whole country | SPF | | | | | | | |
| BPR, BPP, DOR, DOC, HEP, HER, SRA, SRP | | N | | | A | | S2, ST0 |
| EP, E, POU, RAT, WGM | | N | | | | | |
| IL — Israel | IL-0 | Whole country | SPF | | | | | | | |
| BPR, BPP, DOC, DOR, HEP, HER, SRP | | N | | | A | | S5, ST1 |
| WGM | VIII | | | | | | |
| EP, E, POU, RAT | | N | | | | | S4 |
| IN — India | IN-0 | Whole country | EP | | | | | | | |
| IS — Iceland | IS-0 | Whole country | SPF | | | | | | | |
| EP, E | | | | | | | S4 |
| KR — | Republic of Korea |

1.

Part 1 is replaced by the following:

‘PART 1

List of third countries, territories, zones or compartments

ISO code and name of third country or territory

Code of third country, territory, zone or compartment

Description of third country, territory, zone or compartment

Veterinary certificate

Specific conditions

Specific conditions

Avian influenza surveillance status

Avian influenza vaccination status

Salmonella control status

Model(s)

Additional guarantees

Closing date (1)

Opening date (2)

1

2

3

4

5

6

6A

6B

7

8

9

AL — Albania

AL-0

Whole country

EP, E

S4

AR — Argentina

AR-0

Whole country

SPF

POU, RAT, EP, E

A

S4

WGM

VIII

AU — Australia

AU-0

Whole country

SPF

EP, E

S4

BPP, DOC, HEP, SRP

S0, ST0

BPR

I

DOR

II

HER

III

POU

VI

RAT

VII

BR — Brazil

BR-0

Whole country

SPF

BR-1

States of:

Rio Grande do Sul, Santa Catarina, Paraná, São Paulo and Mato Grosso do Sul

RAT, BPR, DOR, HER, SRA

N

A

BR-2

States of:

Mato Grosso, Paraná, Rio Grande do Sul, Santa Catarina and São Paulo

BPP, DOC, HEP, SRP

N

S5, ST0

BR-3

Distrito Federal and States of:

Goiás, Minas Gerais, Mato Grosso, Mato Grosso do Sul, Paraná, Rio Grande do Sul, Santa Catarina and São Paulo

WGM

VIII

EP, E, POU

N

S4

BW — Botswana

BW-0

Whole country

SPF

EP, E

S4

BPR

I

DOR

II

HER

III

RAT

VII

BY — Belarus

BY-0

Whole country

EP and E (both “only for transit through the EU”)

IX

CA — Canada

CA-0

Whole country

SPF

EP, E

S4

BPR, BPP, DOR, HER, SRA, SRP

N

A

S1, ST1

DOC, HEP

L, N

WGM

VIII

POU, RAT

N

CH — Switzerland

CH-0

Whole country

(3)

A

(3)

CL — Chile

CL-0

Whole country

SPF

EP, E

S4

BPR, BPP, DOC, DOR, HEP, HER, SRA, SRP

N

A

S0, ST0

WGM

VIII

POU, RAT

N

CN — China

CN-0

Whole country

EP

CN-1

Province of Shandong

POU, E

VI

P2

6.2.2004

—

S4

GL — Greenland

GL-0

Whole country

SPF

EP, WGM

HK — Hong Kong

HK-0

The whole territory of the Hong Kong Special Administrative Region

EP

HR — Croatia

HR-0

Whole country

SPF

BPR, BPP, DOR, DOC, HEP, HER, SRA, SRP

N

A

S2, ST0

EP, E, POU, RAT, WGM

N

IL — Israel

IL-0

Whole country

SPF

BPR, BPP, DOC, DOR, HEP, HER, SRP

N

A

S5, ST1

WGM

VIII

EP, E, POU, RAT

N

S4

IN — India

IN-0

Whole country

EP

IS — Iceland

IS-0

Whole country

SPF

EP, E

S4

KR —

Republic of Korea

KR-0

Whole country

EP, E

S4

ME — Montenegro

ME-O

Whole country

EP

MG — Madagascar

MG-0

Whole country

SPF

EP, E, WGM

S4

MY — Malaysia

MY-0

—

—

MY-1

Western Peninsular

EP

E

P2

6.2.2004

S4

| MK — | former Yugoslav Republic of Macedonia (4) |
| --- | --- |

MK —

former Yugoslav Republic of Macedonia (4)

MK-0 (4)

Whole country

EP

MX — Mexico

MX-0

Whole country

SPF

EP

NA — Namibia

NA-0

Whole country

SPF

BPR

I

DOR

II

HER

III

RAT, EP, E

VII

S4

| NC — | New Caledonia |
| --- | --- |

NC —

New Caledonia

NC-0

Whole country

EP

NZ — New Zealand

NZ-0

Whole country

SPF

BPR, BPP, DOC, DOR, HEP, HER, SRA, SRP

S0, ST0

WGM

VIII

EP, E, POU, RAT

S4

| PM — | Saint Pierre and Miquelon |
| --- | --- |

PM —

Saint Pierre and Miquelon

PM-0

Whole territory

SPF

RS — Serbia (5)

RS-0 (5)

Whole country

EP

RU — Russia

RU-0

Whole country

EP

SG — Singapore

SG-0

Whole country

EP

TH — Thailand

TH-0

Whole country

SPF, EP

WGM

VIII

P2

23.1.2004

E, POU, RAT

P2

23.1.2004

S4

TN — Tunisia

TN-0

Whole country

SPF

DOR, BPR, BPP, HER

S1, ST0

WGM

VIII

EP, E, POU, RAT

S4

TR — Turkey

TR-0

Whole country

SPF

EP, E

S4

US — United States

US-0

Whole country

SPF

BPR, BPP, DOC, DOR, HEP, HER, SRA, SRP

N

A

S3, ST1

WGM

VIII

EP, E, POU, RAT

N

S4

UY — Uruguay

UY-0

Whole country

SPF

EP, E, RAT

S4

ZA — South Africa

ZA-0

Whole country

SPF

EP, E

S4

BPR

I

A

DOR

II

HER

III

RAT

VII

ZW — Zimbabwe

ZW-0

Whole country

RAT

VII

EP, E

S4

| 2. | Part 2 is amended as follows:






  (a) | in the section on the ‘Salmonella control programme’, the following entries are added:






  ‘ “S5” | Prohibition to export into the Union breeding and productive poultry of Gallus gallus (BPP), slaughter poultry and poultry for restocking (SRP) of Gallus gallus because a Salmonella control programme in accordance with Regulation (EC) No 2160/2003 has not been submitted to the Commission or approved by it. |
| --- | --- | --- | --- |
| “ST0” | Prohibition to export into the Union breeding or productive poultry (BPP) of turkeys, day-old chicks (DOC) of turkeys, slaughter poultry and poultry for restocking (SRP) of turkeys and hatching eggs (HEP) of turkeys because a relevant Salmonella control programme in accordance with Regulation (EC) No 2160/2003 has not been submitted to the Commission or approved by it. |
| “ST1” | Prohibition to export into the Union breeding or productive poultry (BPP) of turkeys and slaughter poultry and poultry for restocking (SRP) of turkeys because a relevant Salmonella control programme in accordance with Regulation (EC) No 2160/2003 has not been submitted to the Commission or approved by it.’; |

2.

Part 2 is amended as follows:

(a)

in the section on the ‘Salmonella control programme’, the following entries are added:

‘ “S5”

Prohibition to export into the Union breeding and productive poultry of Gallus gallus (BPP), slaughter poultry and poultry for restocking (SRP) of Gallus gallus because a Salmonella control programme in accordance with Regulation (EC) No 2160/2003 has not been submitted to the Commission or approved by it.

“ST0”

Prohibition to export into the Union breeding or productive poultry (BPP) of turkeys, day-old chicks (DOC) of turkeys, slaughter poultry and poultry for restocking (SRP) of turkeys and hatching eggs (HEP) of turkeys because a relevant Salmonella control programme in accordance with Regulation (EC) No 2160/2003 has not been submitted to the Commission or approved by it.

“ST1”

Prohibition to export into the Union breeding or productive poultry (BPP) of turkeys and slaughter poultry and poultry for restocking (SRP) of turkeys because a relevant Salmonella control programme in accordance with Regulation (EC) No 2160/2003 has not been submitted to the Commission or approved by it.’;

| (b) | in the model certificate for breeding and productive poultry other than ratites (BPP), note 6 of Part II is replaced by the following:






  ‘(6) | This guarantee applies for poultry belonging to the species of Gallus gallus and turkeys.’; |
| --- | --- | --- |

(b)

in the model certificate for breeding and productive poultry other than ratites (BPP), note 6 of Part II is replaced by the following:

‘(6)

This guarantee applies for poultry belonging to the species of Gallus gallus and turkeys.’;

| (c) | in the model certificate for day-old chicks other than ratites (DOC), note 6 of Part II is replaced by the following:






  ‘(6) | This guarantee applies for poultry belonging to the species of Gallus gallus and turkeys.’; |
| --- | --- | --- |

(c)

in the model certificate for day-old chicks other than ratites (DOC), note 6 of Part II is replaced by the following:

‘(6)

This guarantee applies for poultry belonging to the species of Gallus gallus and turkeys.’;

| (d) | in the model certificate for hatching eggs of poultry other than ratites (HEP), note 5 of Part II is replaced by the following:






  ‘(5) | This guarantee applies for poultry belonging to the species of Gallus gallus and turkeys.’; |
| --- | --- | --- |

(d)

in the model certificate for hatching eggs of poultry other than ratites (HEP), note 5 of Part II is replaced by the following:

‘(5)

This guarantee applies for poultry belonging to the species of Gallus gallus and turkeys.’;

| (e) | in the model certificate for slaughter poultry and poultry for restocking game supplies other than ratites (SRP), note 6 of Part II is replaced by the following:






  ‘(6) | This guarantee applies for poultry belonging to the species of Gallus gallus and turkeys.’. |
| --- | --- | --- |

(e)

in the model certificate for slaughter poultry and poultry for restocking game supplies other than ratites (SRP), note 6 of Part II is replaced by the following:

‘(6)

This guarantee applies for poultry belonging to the species of Gallus gallus and turkeys.’.

---

(1)  Commodities, including those transported on the high seas, produced before this date may be imported into the Union during a period of 90 days from this date.

(2)  Only commodities produced after this date may be imported into the Union.

(3)  In accordance with the agreement between the European Union and the Swiss Confederation on trade in agricultural products (OJ L 114, 30.4.2002, p. 132).

(4)  The former Yugoslav Republic of Macedonia; provisional code that does not prejudge in any way the definitive nomenclature for this country, which will be agreed following the conclusion of negotiations currently taking place on this subject in the United Nations.

(5)  Not including Kosovo, as defined by United Nations Security Council Resolution 1244 of 10 June 1999.’

---

| 26.3.2010 | EN | Official Journal of the European Union | L 80/10 |
| --- | --- | --- | --- |

26.3.2010

EN

Official Journal of the European Union

L 80/10

---

COMMISSION REGULATION (EU) No 255/2010

of 25 March 2010

laying down common rules on air traffic flow management

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 551/2004 of the European Parliament and of the Council of 10 March 2004 on the organisation and the use of the airspace in the single European sky (the airspace Regulation) (1) and in particular Article 6(7) thereof,

Whereas:

| (1) | The Commission is required to lay down measures regarding air traffic flow management (hereinafter ATFM) with a view to optimising available capacity in the use of airspace and enhancing ATFM processes. |
| --- | --- |

(1)

The Commission is required to lay down measures regarding air traffic flow management (hereinafter ATFM) with a view to optimising available capacity in the use of airspace and enhancing ATFM processes.

| (2) | The European Organisation for the Safety of Air Navigation (Eurocontrol) has been mandated in accordance with Article 8(1) of Regulation (EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the single European sky (the framework Regulation) (2) to develop implementing rules for ATFM. This Regulation is based on the resulting mandate report of 7 December 2007. |
| --- | --- |

(2)

The European Organisation for the Safety of Air Navigation (Eurocontrol) has been mandated in accordance with Article 8(1) of Regulation (EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the single European sky (the framework Regulation) (2) to develop implementing rules for ATFM. This Regulation is based on the resulting mandate report of 7 December 2007.

| (3) | The uniform application of specific rules and procedures within the airspace of the single European sky is critical for the achievement of the optimum use of available air traffic control capacity through the efficient management and operation of the ATFM function. |
| --- | --- |

(3)

The uniform application of specific rules and procedures within the airspace of the single European sky is critical for the achievement of the optimum use of available air traffic control capacity through the efficient management and operation of the ATFM function.

| (4) | This Regulation should not cover military operations and training as referred to in Article 1(2) of Regulation (EC) No 549/2004. However military aircraft operating as general air traffic should be subject to ATFM measures when operating or intending to operate within airspace or airports to which ATFM measures apply. |
| --- | --- |

(4)

This Regulation should not cover military operations and training as referred to in Article 1(2) of Regulation (EC) No 549/2004. However military aircraft operating as general air traffic should be subject to ATFM measures when operating or intending to operate within airspace or airports to which ATFM measures apply.

| (5) | In accordance with Article 13 of Regulation (EC) No 549/2004, Member States’ essential security or defence policy interests should be safeguarded in the definition and implementation of ATFM measures. |
| --- | --- |

(5)

In accordance with Article 13 of Regulation (EC) No 549/2004, Member States’ essential security or defence policy interests should be safeguarded in the definition and implementation of ATFM measures.

| (6) | A single central unit for ATFM in charge of planning, coordination and execution of ATFM measures has been established by Eurocontrol taking into consideration the recommendations of the International Civil Aviation Organisation (ICAO). Member States should be required to take the necessary measures to ensure that the central unit for ATFM optimises the overall effects of ATFM measures on the European air traffic management network (hereinafter EATMN). |
| --- | --- |

(6)

A single central unit for ATFM in charge of planning, coordination and execution of ATFM measures has been established by Eurocontrol taking into consideration the recommendations of the International Civil Aviation Organisation (ICAO). Member States should be required to take the necessary measures to ensure that the central unit for ATFM optimises the overall effects of ATFM measures on the European air traffic management network (hereinafter EATMN).

| (7) | ATFM measures should be based on principles laid down by ICAO and all parties in the ATFM system should adhere to rules that ensure that air traffic control capacity is used safely and to the maximum extent possible. |
| --- | --- |

(7)

ATFM measures should be based on principles laid down by ICAO and all parties in the ATFM system should adhere to rules that ensure that air traffic control capacity is used safely and to the maximum extent possible.

| (8) | ATFM measures should take into account the availability of routes and airspace in particular through the application of the flexible use of airspace by all relevant parties including the airspace management cell laid down by Commission Regulation (EC) No 2150/2005 of 23 December 2005 laying down common rules for the flexible use of airspace (3). |
| --- | --- |

(8)

ATFM measures should take into account the availability of routes and airspace in particular through the application of the flexible use of airspace by all relevant parties including the airspace management cell laid down by Commission Regulation (EC) No 2150/2005 of 23 December 2005 laying down common rules for the flexible use of airspace (3).

| (9) | In order to optimise available capacity of the EATMN, including airports, procedures aimed at increasing the consistency between airport slots and flight plans should be established. |
| --- | --- |

(9)

In order to optimise available capacity of the EATMN, including airports, procedures aimed at increasing the consistency between airport slots and flight plans should be established.

| (10) | It is appropriate to provide Member States and parties involved in ATFM processes with sufficient time to comply with requirements for air traffic flow management. |
| --- | --- |

(10)

It is appropriate to provide Member States and parties involved in ATFM processes with sufficient time to comply with requirements for air traffic flow management.

| (11) | The measures provided for in this Regulation are in accordance with the opinion of the Single Sky Committee, |
| --- | --- |

(11)

The measures provided for in this Regulation are in accordance with the opinion of the Single Sky Committee,

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter and scope

1.   This Regulation lays down the requirements for air traffic flow management (hereinafter ATFM) in order to optimise the available capacity of the European air traffic management network (hereinafter EATMN) and enhance ATFM processes.

2.   This Regulation shall apply within the airspace referred to in Article 1(3) of Regulation (EC) No 551/2004 to:

| (a) | all flights intended to operate or operating as general air traffic and in accordance with the instrument flight rules (hereinafter IFR) in whole or in part; |
| --- | --- |

(a)

all flights intended to operate or operating as general air traffic and in accordance with the instrument flight rules (hereinafter IFR) in whole or in part;

| (b) | all phases of flights referred to in point (a) and air traffic management. |
| --- | --- |

(b)

all phases of flights referred to in point (a) and air traffic management.

3.   This Regulation shall apply to the following parties, or agents acting on their behalf, involved in ATFM processes:

| (a) | operators of aircraft, |
| --- | --- |

(a)

operators of aircraft,

| (b) | air traffic service (hereinafter ATS) units, including ATS reporting offices and aerodrome control services; |
| --- | --- |

(b)

air traffic service (hereinafter ATS) units, including ATS reporting offices and aerodrome control services;

| (c) | aeronautical information services; |
| --- | --- |

(c)

aeronautical information services;

| (d) | entities involved in airspace management; |
| --- | --- |

(d)

entities involved in airspace management;

| (e) | airport managing bodies; |
| --- | --- |

(e)

airport managing bodies;

| (f) | the central unit for ATFM; |
| --- | --- |

(f)

the central unit for ATFM;

| (g) | local ATFM units; |
| --- | --- |

(g)

local ATFM units;

| (h) | slot coordinators of coordinated airports. |
| --- | --- |

(h)

slot coordinators of coordinated airports.

Article 2

Definitions

For the purposes of this Regulation the definitions provided for in Article 2 of Regulation (EC) No 549/2004 and Article 2 of Council Regulation (EEC) No 95/93 (4) shall apply.

The following definitions shall also apply:

| 1. | ‘air traffic flow management (ATFM) measure’ means the actions taken to perform air traffic flow management and capacity management; |
| --- | --- |

1.

‘air traffic flow management (ATFM) measure’ means the actions taken to perform air traffic flow management and capacity management;

| 2. | ‘operator’ means a person, organisation or enterprise engaged in or offering to engage in an aircraft operation; |
| --- | --- |

2.

‘operator’ means a person, organisation or enterprise engaged in or offering to engage in an aircraft operation;

| 3. | ‘instrument flight rules (IFR)’ means instrument flight rules as defined in Annex 2 of the 1944 Chicago Convention on International Civil Aviation (hereinafter Chicago Convention); |
| --- | --- |

3.

‘instrument flight rules (IFR)’ means instrument flight rules as defined in Annex 2 of the 1944 Chicago Convention on International Civil Aviation (hereinafter Chicago Convention);

| 4. | ‘air traffic services (ATS) reporting office’ means an ATS unit established for the purpose of receiving reports concerning ATS and flight plans submitted before the first delivery of an air traffic control clearance; |
| --- | --- |

4.

‘air traffic services (ATS) reporting office’ means an ATS unit established for the purpose of receiving reports concerning ATS and flight plans submitted before the first delivery of an air traffic control clearance;

| 5. | ‘local air traffic flow management (ATFM) unit’ means a flow management entity operating on behalf of one or more other flow management entities as the interface between the central unit for ATFM and an ATS unit or a group of such units; |
| --- | --- |

5.

‘local air traffic flow management (ATFM) unit’ means a flow management entity operating on behalf of one or more other flow management entities as the interface between the central unit for ATFM and an ATS unit or a group of such units;

| 6. | ‘critical event’ means an unusual situation or crisis involving a major loss of EATMN capacity, or a major imbalance between EATMN capacity and demand, or a major failure in the information flow in one or several parts of the EATMN; |
| --- | --- |

6.

‘critical event’ means an unusual situation or crisis involving a major loss of EATMN capacity, or a major imbalance between EATMN capacity and demand, or a major failure in the information flow in one or several parts of the EATMN;

| 7. | ‘air traffic flow management (ATFM) departure slot’ means a calculated take-off time attributed by the central unit for ATFM with a time tolerance managed by the local ATS unit; |
| --- | --- |

7.

‘air traffic flow management (ATFM) departure slot’ means a calculated take-off time attributed by the central unit for ATFM with a time tolerance managed by the local ATS unit;

| 8. | ‘route and traffic orientation’ means policies and procedures for the use of routes by aircraft; |
| --- | --- |

8.

‘route and traffic orientation’ means policies and procedures for the use of routes by aircraft;

| 9. | ‘multiple flight plan’ means more than one flight plan for the same intended flight between two airports; |
| --- | --- |

9.

‘multiple flight plan’ means more than one flight plan for the same intended flight between two airports;

| 10. | ‘air traffic service (ATS) unit sector configuration’ means the four dimensional description of an ATS unit airspace sector, or group of sectors, which may be operated on a permanent or temporary basis; |
| --- | --- |

10.

‘air traffic service (ATS) unit sector configuration’ means the four dimensional description of an ATS unit airspace sector, or group of sectors, which may be operated on a permanent or temporary basis;

| 11. | ‘aerodrome taxi time’ means the pre-determined time value from off-block to take-off, expressed in minutes and valid during normal airport operations; |
| --- | --- |

11.

‘aerodrome taxi time’ means the pre-determined time value from off-block to take-off, expressed in minutes and valid during normal airport operations;

| 12. | ‘updated flight position’ means aircraft position, updated by surveillance data, flight plan data or position reports; |
| --- | --- |

12.

‘updated flight position’ means aircraft position, updated by surveillance data, flight plan data or position reports;

| 13. | ‘air traffic control clearance’ means the authorisation for an aircraft to proceed under conditions specified by an air traffic control unit; |
| --- | --- |

13.

‘air traffic control clearance’ means the authorisation for an aircraft to proceed under conditions specified by an air traffic control unit;

| 14. | ‘flight plan suspension’ means the process initiated by an entity performing ATFM to ensure that a change is made to the flight plan by the operator before the execution of the flight; |
| --- | --- |

14.

‘flight plan suspension’ means the process initiated by an entity performing ATFM to ensure that a change is made to the flight plan by the operator before the execution of the flight;

| 15. | ‘air service’ means a flight or a series of flights carrying passengers, cargo or mail for remuneration or hire; |
| --- | --- |

15.

‘air service’ means a flight or a series of flights carrying passengers, cargo or mail for remuneration or hire;

| 16. | ‘operational log’ means a log of the ATFM system, converted into a database to allow quick search of ATFM data. |
| --- | --- |

16.

‘operational log’ means a log of the ATFM system, converted into a database to allow quick search of ATFM data.

Article 3

Air traffic flow management framework

1.   The planning, coordination and execution of the ATFM measures by the parties referred to in Article 1(3) shall comply with the ICAO provisions specified in the Annex.

2.   ATFM shall be governed by the following principles:

| (a) | ATFM measures shall:






  (i) | prevent excessive air traffic demand compared with declared air traffic control (ATC) capacity of sectors and airports; |
| --- | --- | --- |

(a)

ATFM measures shall:

(i)

prevent excessive air traffic demand compared with declared air traffic control (ATC) capacity of sectors and airports;

| (ii) | use EATMN capacity to the maximum extent possible in order to optimise the efficiency of the EATMN and minimise adverse effects on operators; |
| --- | --- |

(ii)

use EATMN capacity to the maximum extent possible in order to optimise the efficiency of the EATMN and minimise adverse effects on operators;

| (iii) | optimise the EATMN capacity made available through the development and application of capacity enhancing measures by ATS units; |
| --- | --- |

(iii)

optimise the EATMN capacity made available through the development and application of capacity enhancing measures by ATS units;

| (iv) | support the management of critical events; |
| --- | --- |

(iv)

support the management of critical events;

| (b) | local ATFM units and the central unit for ATFM shall be considered as part of the ATFM function. |
| --- | --- |

(b)

local ATFM units and the central unit for ATFM shall be considered as part of the ATFM function.

3.   The allocation of ATFM departure slots shall give priority to flights according to the order of their planned entry into the location at which the ATFM measure will apply, unless specific circumstances require application of a different priority rule which is formally agreed and is of benefit to the EATMN.

The first subparagraph may be applied to flights which are unable to accept the re-routing option to avoid or alleviate congested areas, taking into consideration the location and extent of the congested area.

Article 4

General obligations of Member States

1.   Member States shall ensure that the ATFM function is available to parties referred to in Article 1(3) on a 24 hour basis.

2.   The definition and implementation of ATFM measures shall be compatible with Member States security and defence requirements, in order to ensure efficiency in airspace planning, allocation and use for the benefit of parties referred in Article 1(3).

3.   Consistent procedures shall be established for the cooperation between the parties involved in ATFM function, ATS units and entities involved in airspace management, in order to optimise the use of the airspace.

4.   A common reference document containing the policies, procedures and description for route and traffic orientation shall be created. Where applicable, publication of route availability in national aeronautical information publications shall be fully consistent with this common reference document.

5.   Common procedures for requesting exemption from an ATFM departure slot shall be drawn up in accordance with the ICAO provisions specified in the Annex. Those procedures shall be coordinated with the central unit for ATFM and published in national aeronautical information publications.

Article 5

Obligations of Member States concerning the central unit for ATFM

Member States shall ensure that the central unit for ATFM:

| (a) | optimises the overall performance effects on the EATMN through planning, coordination and implementation of ATFM measures; |
| --- | --- |

(a)

optimises the overall performance effects on the EATMN through planning, coordination and implementation of ATFM measures;

| (b) | consults with operators on the definition of ATFM measures; |
| --- | --- |

(b)

consults with operators on the definition of ATFM measures;

| (c) | ensures the effective implementation of ATFM measures, together with local ATFM units; |
| --- | --- |

(c)

ensures the effective implementation of ATFM measures, together with local ATFM units;

| (d) | in coordination with local ATFM units identifies alternative routings to avoid or alleviate congested areas, taking into account the overall performance effects on the EATMN; |
| --- | --- |

(d)

in coordination with local ATFM units identifies alternative routings to avoid or alleviate congested areas, taking into account the overall performance effects on the EATMN;

| (e) | offers a re-routing to those flights that would optimise the effect of point (d); |
| --- | --- |

(e)

offers a re-routing to those flights that would optimise the effect of point (d);

| (f) | provides information on ATFM in a timely manner to operators and ATS units, including:






  (i) | planned ATFM measures; |
| --- | --- | --- |

(f)

provides information on ATFM in a timely manner to operators and ATS units, including:

(i)

planned ATFM measures;

| (ii) | impact of ATFM measures on take-off time and flight profile of individual flights; |
| --- | --- |

(ii)

impact of ATFM measures on take-off time and flight profile of individual flights;

| (g) | monitors the occurrences of missing flight plans and multiple flight plans that are filed; |
| --- | --- |

(g)

monitors the occurrences of missing flight plans and multiple flight plans that are filed;

| (h) | suspends a flight plan when, considering the time tolerance, the ATFM departure slot cannot be met and a new estimated off-block time is not known; |
| --- | --- |

(h)

suspends a flight plan when, considering the time tolerance, the ATFM departure slot cannot be met and a new estimated off-block time is not known;

| (i) | monitors the number of exemptions granted in accordance with Article 4(5). |
| --- | --- |

(i)

monitors the number of exemptions granted in accordance with Article 4(5).

Article 6

General obligations of ATS units

1.   When an ATFM measure has to be applied, ATS units shall coordinate through the local ATFM unit with the central unit for ATFM in order to ensure that the choice of measure is made with respect to the optimisation of the overall performance effects on the EATMN.

2.   When necessary, ATS reporting offices shall facilitate the exchange of information between pilots or operators and the local or the central unit for ATFM.

3.   ATS units shall ensure that ATFM measures applied to airports are coordinated with the airport managing body concerned, in order to ensure efficiency in airport planning and usage for the benefit of parties referred to in Article 1(3).

4.   ATS units shall notify to the central unit for ATFM through the local ATFM unit all events that may impact air traffic control capacity or air traffic demand.

5.   ATS units shall provide the central unit for ATFM with the following data and subsequent updates, in a timely manner and ensuring its quality:

| (a) | availability of airspace and route structures, |
| --- | --- |

(a)

availability of airspace and route structures,

| (b) | ATS unit sector configurations and activations, |
| --- | --- |

(b)

ATS unit sector configurations and activations,

| (c) | aerodrome taxi times, |
| --- | --- |

(c)

aerodrome taxi times,

| (d) | air traffic control sector and airport capacities, |
| --- | --- |

(d)

air traffic control sector and airport capacities,

| (e) | route availability including availability through application of flexible use of airspace in accordance with Regulation (EC) No 2150/2005, |
| --- | --- |

(e)

route availability including availability through application of flexible use of airspace in accordance with Regulation (EC) No 2150/2005,

| (f) | updated flight positions, |
| --- | --- |

(f)

updated flight positions,

| (g) | deviations from flight plans, |
| --- | --- |

(g)

deviations from flight plans,

| (h) | airspace availability including availability through application of flexible use of airspace in accordance with Regulation (EC) No 2150/2005, |
| --- | --- |

(h)

airspace availability including availability through application of flexible use of airspace in accordance with Regulation (EC) No 2150/2005,

| (i) | actual flight take-off times. |
| --- | --- |

(i)

actual flight take-off times.

The data shall be made available to parties referred to in Article 1(3) and provided free of charge to, and by, the central unit for ATFM.

6.   The ATS unit at the departure airport shall ensure that:

| (a) | where a flight is subject to an ATFM departure slot, that slot is included as part of the air traffic control clearance; |
| --- | --- |

(a)

where a flight is subject to an ATFM departure slot, that slot is included as part of the air traffic control clearance;

| (b) | flights adhere to ATFM departure slots; |
| --- | --- |

(b)

flights adhere to ATFM departure slots;

| (c) | flights not adhering to their estimated off blocks time, taking into account the established time tolerance, are not given take-off clearance; |
| --- | --- |

(c)

flights not adhering to their estimated off blocks time, taking into account the established time tolerance, are not given take-off clearance;

| (d) | flights whose flight plan has been rejected or suspended are not given take-off clearance. |
| --- | --- |

(d)

flights whose flight plan has been rejected or suspended are not given take-off clearance.

Article 7

General obligations of operators

1.   Each intended flight shall be covered by a single flight plan. The filed flight plan shall correctly reflect the intended flight profile.

2.   All relevant ATFM measures and changes thereto shall be incorporated into the planned flight operation and communicated to the pilot.

3.   Where departing from an airport not subject to an ATFM departure slot, operators are responsible for adhering to their estimated off blocks time, taking into account a time tolerance as laid down in relevant ICAO provisions specified in the Annex.

4.   Where a flight plan has been suspended in accordance with Article 5(h), the operator concerned shall arrange for updating or cancelling the flight plan.

Article 8

General obligations of airport managing bodies

Airport managing bodies shall notify to the central unit for ATFM, directly or through the local ATFM unit or ATS units or both, all events that may impact air traffic control capacity or air traffic demand. They shall inform the local ATFM unit and ATS units where the notification is done directly.

Article 9

Consistency between flight plans and airport slots

1.   Member States shall ensure that, where requested by an airport slot coordinator or a managing body of a coordinated airport, the central unit for ATFM or the local ATFM unit shall provide them with the accepted flight plan of a flight operating at that airport, before that flight takes place. The airport slot coordinators or the managing bodies of coordinated airports shall arrange access to the accepted flight plans provided by the central unit for ATFM or the local ATFM unit.

2.   Before flight, operators shall provide airports of departure and arrival with the necessary information to enable a correlation to be made between the flight designator contained in the flight plan and that notified for the corresponding airport slot.

3.   Any operator, airport managing body and ATS unit shall be entitled to report to the airport slot coordinator on repeated operation of air services at times that are significantly different from the allocated airport slots or with the use of slots in a significantly different way from that indicated at the time of allocation, where this causes prejudice to airport or air traffic operations.

4.   Member States shall ensure that the central unit for ATFM reports to the airport slot coordinators on repeated operation of air services at significantly different times from the allocated airport slots or with the use of slots in a significantly different way from that indicated at the time of allocation, where this causes prejudice to ATFM.

Article 10

Obligations concerning critical events

1.   Member States shall ensure that ATFM procedures for handling critical events are established and published by the central unit for ATFM, in order to minimise disruption to the EATMN.

2.   In the preparation for critical events, ATS units and airport managing bodies shall coordinate the relevance and content of the contingency procedures with operators affected by critical events, including any adjustment to priority rules.

The contingency procedures shall include:

| (a) | organisational and coordination arrangements, |
| --- | --- |

(a)

organisational and coordination arrangements,

| (b) | ATFM measures to manage access to affected areas to prevent excessive air traffic demand compared with declared capacity of the whole or part of the airspace or airports concerned, |
| --- | --- |

(b)

ATFM measures to manage access to affected areas to prevent excessive air traffic demand compared with declared capacity of the whole or part of the airspace or airports concerned,

| (c) | circumstances, conditions and procedures for the application of priority rules for flights, which respect Member States’ essential security or defence policy interests, |
| --- | --- |

(c)

circumstances, conditions and procedures for the application of priority rules for flights, which respect Member States’ essential security or defence policy interests,

| (d) | recovery arrangements. |
| --- | --- |

(d)

recovery arrangements.

Article 11

Monitoring of compliance to ATFM measures

1.   Member States shall ensure that where adherence to ATFM departure slots at an airport of departure is 80 % or less during a year, the ATS unit at that airport shall provide relevant information of non-compliance and the actions taken to ensure adherence to ATFM departure slots. Such actions shall be indicated in a report to be submitted by the Member State concerned to the Commission.

2.   The ATS unit at that airport concerned shall provide relevant information on any failure to adhere to flight plan rejections or suspensions at that airport and of the actions taken to ensure adherence. Such actions shall be indicated in a report to be submitted by the Member State concerned to the Commission.

3.   Member States shall ensure that:

| (a) | the central unit for ATFM notifies a Member State which grants exemptions in excess of 0,6 % of that Member State’s annual departures; |
| --- | --- |

(a)

the central unit for ATFM notifies a Member State which grants exemptions in excess of 0,6 % of that Member State’s annual departures;

| (b) | where a Member State has been notified under point (a), it shall produce a report providing details of the exemptions granted to be submitted to the Commission. |
| --- | --- |

(b)

where a Member State has been notified under point (a), it shall produce a report providing details of the exemptions granted to be submitted to the Commission.

4.   Member States shall ensure that where a non-compliance to ATFM measures resulting from application of Article 5(g) is identified, the central unit for ATFM shall notify the operator of the non-compliance.

5.   Operators shall submit a report to the central unit for ATFM on each non-compliance to ATFM measures providing details of the circumstances that resulted in a missing flight plan or multiple flight plans and the actions taken to correct such non-compliance.

6.   Member States shall ensure that the central unit for ATFM produces an annual report providing details of missing flight plans, or multiple flight plans that are filed and that the report is submitted to the Commission.

7.   Member States shall conduct an annual review of adherence to ATFM measures to ensure that parties referred to in Article 1(3) improve the level of adherence to those measures.

Article 12

Performance assessment

1.   When implementing Article 11, Member States shall ensure that the central unit for ATFM produces annual reports indicating the quality of the ATFM that shall include details of:

| (a) | causes of ATFM measures; |
| --- | --- |

(a)

causes of ATFM measures;

| (b) | impact of ATFM measures; |
| --- | --- |

(b)

impact of ATFM measures;

| (c) | adherence to ATFM measures; |
| --- | --- |

(c)

adherence to ATFM measures;

| (d) | contributions by parties referred to in Article 1(3) to the optimisation of the overall network effect. |
| --- | --- |

(d)

contributions by parties referred to in Article 1(3) to the optimisation of the overall network effect.

2.   Member States shall ensure that an archive of ATFM data listed in Article 6(5), flight plans, operational logs and relevant contextual data is created and maintained by the central unit for ATFM.

The data referred to in the first subparagraph shall be retained for 2 years from their submission and made available to the Commission, Member States, ATS units and operators.

That data shall be made available to airport coordinators and airport operators to assist their regular assessment of the declared capacity.

Article 13

Safety requirements

Member States shall ensure that a safety assessment, including hazard identification, risk assessment and mitigation, is conducted, before any significant changes to ATFM systems and procedures are introduced, including an assessment of a safety management process addressing the complete lifecycle of the air traffic management system.

Article 14

Additional requirements

1.   Member States shall ensure that personnel of the parties referred to in Article 1(3) involved in ATFM activities are:

| (a) | made duly aware of the provisions of this Regulation; |
| --- | --- |

(a)

made duly aware of the provisions of this Regulation;

| (b) | adequately trained and competent for their job functions. |
| --- | --- |

(b)

adequately trained and competent for their job functions.

2.   Member States shall take the necessary measures to ensure that parties referred to in Article 1(3) with responsibilities for ATFM functions:

| (a) | develop and maintain operations manuals containing the necessary instructions and information to enable their operations personnel to apply the provisions of this Regulation; |
| --- | --- |

(a)

develop and maintain operations manuals containing the necessary instructions and information to enable their operations personnel to apply the provisions of this Regulation;

| (b) | ensure that these manuals are consistent, accessible and kept up-to-date and that their update and distribution are subject to appropriate quality and documentation configuration management; |
| --- | --- |

(b)

ensure that these manuals are consistent, accessible and kept up-to-date and that their update and distribution are subject to appropriate quality and documentation configuration management;

| (c) | ensure that the working methods and operating procedures comply with this Regulation. |
| --- | --- |

(c)

ensure that the working methods and operating procedures comply with this Regulation.

Article 15

Penalties

Member States shall lay down the rules on penalties applicable to infringements of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by 26 September 2011 at the latest and shall notify it without delay of any subsequent amendment affecting them.

Article 16

Entry into force and application

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 26 September 2011.

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

Done at Brussels, 25 March 2010.

For the Commission

The President

José Manuel BARROSO

---

(1)  OJ L 96, 31.3.2004, p. 20.

1

(2)  OJ L 96, 31.3.2004, p. 1.

2

(3)  OJ L 342, 24.12.2005, p. 20.

3

(4)  OJ L 14, 22.1.1993, p. 1.

4

---

ANNEX

List of the ICAO provisions for the purposes of air traffic flow management

| 1. | Chapter 3 paragraph 3.7.5 (Air Traffic Flow Management) of Annex 11 to the Chicago Convention — Air Traffic Services (13th edition — July 2001, incorporating amendment No 47). |
| --- | --- |

1.

Chapter 3 paragraph 3.7.5 (Air Traffic Flow Management) of Annex 11 to the Chicago Convention — Air Traffic Services (13th edition — July 2001, incorporating amendment No 47).

| 2. | Chapter 3 (ATS Capacity and Air Traffic Flow Management) of ICAO Doc 4444, Procedures for Air Navigation Services — Air Traffic Management (PANS-ATM) (15th edition — 2007). |
| --- | --- |

2.

Chapter 3 (ATS Capacity and Air Traffic Flow Management) of ICAO Doc 4444, Procedures for Air Navigation Services — Air Traffic Management (PANS-ATM) (15th edition — 2007).

| 3. | Chapter 8.3 (exemptions from ATFM slot allocation) of ICAO Doc 7030, European (EUR) Regional Supplementary Procedures (5th edition 2007). |
| --- | --- |

3.

Chapter 8.3 (exemptions from ATFM slot allocation) of ICAO Doc 7030, European (EUR) Regional Supplementary Procedures (5th edition 2007).

| 4. | Chapter 8.4 1.c) (Aircraft operator adherence to ATFM measures) of ICAO Doc 7030, European (EUR) Regional Supplementary Procedures (5th edition 2007). |
| --- | --- |

4.

Chapter 8.4 1.c) (Aircraft operator adherence to ATFM measures) of ICAO Doc 7030, European (EUR) Regional Supplementary Procedures (5th edition 2007).

| 5. | Chapter 2 paragraph 2.3.2 (Changes to EOBT) of ICAO Doc 7030, European (EUR) Region Supplementary Procedures (5th edition 2007). |
| --- | --- |

5.

Chapter 2 paragraph 2.3.2 (Changes to EOBT) of ICAO Doc 7030, European (EUR) Region Supplementary Procedures (5th edition 2007).

---

| 26.3.2010 | EN | Official Journal of the European Union | L 80/17 |
| --- | --- | --- | --- |

26.3.2010

EN

Official Journal of the European Union

L 80/17

---

COMMISSION REGULATION (EU) No 256/2010

of 25 March 2010

entering a name in the register of protected designations of origin and protected geographical indications (Alubia de La Bañeza-León (PGI))

THE EUROPEAN COMMISSION,

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

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

Whereas:

| (1) | Pursuant to the first subparagraph of Article 6(2) and in accordance with Article 17(2) of Regulation (EC) No 510/2006, Spain’s application to register the name ‘Alubia de La Bañeza-León’ was published in the Official Journal of the European Union
   (2). |
| --- | --- |

(1)

Pursuant to the first subparagraph of Article 6(2) and in accordance with Article 17(2) of Regulation (EC) No 510/2006, Spain’s application to register the name ‘Alubia de La Bañeza-León’ was published in the Official Journal of the European Union
   (2).

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

(2)

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

HAS ADOPTED THIS REGULATION:

Article 1

The name contained in the Annex to this Regulation is hereby 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, 25 March 2010.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  OJ C 186, 8.8.2009, p. 28.

2

---

ANNEX

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

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

SPAIN

Alubia de La Bañeza-León (PGI)

---

| 26.3.2010 | EN | Official Journal of the European Union | L 80/19 |
| --- | --- | --- | --- |

26.3.2010

EN

Official Journal of the European Union

L 80/19

---

COMMISSION REGULATION (EU) No 257/2010

of 25 March 2010

setting up a programme for the re-evaluation of approved food additives in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 32 thereof,

After consulting the European Food Safety Authority,

Whereas:

| (1) | Regulation (EC) No 1333/2008 requires the Commission to set up a programme for the re-evaluation, by the European Food Safety Authority (hereinafter referred to as ‘EFSA’), of the safety of food additives that were already permitted in the Union before 20 January 2009. |
| --- | --- |

(1)

Regulation (EC) No 1333/2008 requires the Commission to set up a programme for the re-evaluation, by the European Food Safety Authority (hereinafter referred to as ‘EFSA’), of the safety of food additives that were already permitted in the Union before 20 January 2009.

| (2) | In 2007, the Commission presented a report to the European Parliament and the Council on the progress of the re-evaluation of food additives (2). That report provides a summary of the recent additive re-evaluations undertaken by the Scientific Committee on Food (‘SCF’) and EFSA and describes the related actions taken by the European Commission on the basis of the scientific opinions. |
| --- | --- |

(2)

In 2007, the Commission presented a report to the European Parliament and the Council on the progress of the re-evaluation of food additives (2). That report provides a summary of the recent additive re-evaluations undertaken by the Scientific Committee on Food (‘SCF’) and EFSA and describes the related actions taken by the European Commission on the basis of the scientific opinions.

| (3) | The re-evaluation of food colours has already been started with priority, since these food additives have the oldest evaluations by the SCF. The re-evaluation of certain colours (namely E 102 Tartrazine, E 104 Quinoline Yellow, E 110 Sunset Yellow FCF, E 124 Ponceau 4R, E 129 Allura Red AC and E 122 Carmoisine, E 160d lycopene) has already been completed. In addition, some food additives such as E 234 Nisin and E 214–219 Para-hydroxybenzoates were re-evaluated in recent years since new scientific data was requested or became otherwise available. As a consequence, those additives do not need to be re-evaluated again. |
| --- | --- |

(3)

The re-evaluation of food colours has already been started with priority, since these food additives have the oldest evaluations by the SCF. The re-evaluation of certain colours (namely E 102 Tartrazine, E 104 Quinoline Yellow, E 110 Sunset Yellow FCF, E 124 Ponceau 4R, E 129 Allura Red AC and E 122 Carmoisine, E 160d lycopene) has already been completed. In addition, some food additives such as E 234 Nisin and E 214–219 Para-hydroxybenzoates were re-evaluated in recent years since new scientific data was requested or became otherwise available. As a consequence, those additives do not need to be re-evaluated again.

| (4) | Taking into account that sweeteners have the most recent evaluations they should be re-evaluated the last. |
| --- | --- |

(4)

Taking into account that sweeteners have the most recent evaluations they should be re-evaluated the last.

| (5) | The order of priorities for the re-evaluation of the currently approved food additives should be set on the basis of the following criteria: the time since the last evaluation of a food additive by the SCF or by EFSA, the availability of new scientific evidence, the extent of use of a food additive in food and the human exposure to the food additive taking also into account the outcome of the Report from the Commission on Dietary Food Additive Intake in the EU (3) of 2001. The report ‘Food additives in Europe 2000 (4)’ submitted by the Nordic Council of Ministers to the Commission, provides additional information for the prioritisation of additives for re-evaluation. |
| --- | --- |

(5)

The order of priorities for the re-evaluation of the currently approved food additives should be set on the basis of the following criteria: the time since the last evaluation of a food additive by the SCF or by EFSA, the availability of new scientific evidence, the extent of use of a food additive in food and the human exposure to the food additive taking also into account the outcome of the Report from the Commission on Dietary Food Additive Intake in the EU (3) of 2001. The report ‘Food additives in Europe 2000 (4)’ submitted by the Nordic Council of Ministers to the Commission, provides additional information for the prioritisation of additives for re-evaluation.

| (6) | For efficiency and practical purposes, the re-evaluation should, as far as possible, be conducted by group of food additives according to the main functional class to which they belong. EFSA should however be in a position to start the re-evaluation of a food additive or a group of food additives with higher priority, on a request from the Commission or on its own initiative, if new scientific evidence emerges that indicates a possible risk for human health or which in any way may affect the assessment of the safety of a food additive. |
| --- | --- |

(6)

For efficiency and practical purposes, the re-evaluation should, as far as possible, be conducted by group of food additives according to the main functional class to which they belong. EFSA should however be in a position to start the re-evaluation of a food additive or a group of food additives with higher priority, on a request from the Commission or on its own initiative, if new scientific evidence emerges that indicates a possible risk for human health or which in any way may affect the assessment of the safety of a food additive.

| (7) | Deadlines for the re-evaluation should be established in accordance with that order of priorities. In duly justified cases and only when such re-evaluation may delay substantially the re-evaluation of other food additives, the deadlines laid down in this Regulation may be revised. |
| --- | --- |

(7)

Deadlines for the re-evaluation should be established in accordance with that order of priorities. In duly justified cases and only when such re-evaluation may delay substantially the re-evaluation of other food additives, the deadlines laid down in this Regulation may be revised.

| (8) | More specific deadlines for individual food additives or groups of food additives may be set in the future, in order to allow the smooth running of the re-evaluation process or in case of emerging concern. |
| --- | --- |

(8)

More specific deadlines for individual food additives or groups of food additives may be set in the future, in order to allow the smooth running of the re-evaluation process or in case of emerging concern.

| (9) | In order for the re-evaluation procedure to be effective, it is important that EFSA acquires from the interested parties all data relevant to the re-evaluation and that the interested parties are informed well in advance when additional data is necessary for the completion of the re-evaluation of a food additive. |
| --- | --- |

(9)

In order for the re-evaluation procedure to be effective, it is important that EFSA acquires from the interested parties all data relevant to the re-evaluation and that the interested parties are informed well in advance when additional data is necessary for the completion of the re-evaluation of a food additive.

| (10) | Business operators interested in the continuity of the approval of a food additive under re-evaluation should submit any data relevant to the re-evaluation of the food additive. Where possible, business operators should take steps to submit information collectively. |
| --- | --- |

(10)

Business operators interested in the continuity of the approval of a food additive under re-evaluation should submit any data relevant to the re-evaluation of the food additive. Where possible, business operators should take steps to submit information collectively.

| (11) | EFSA should make public one or more open calls for data on all food additives to be re-evaluated. Any technical and scientific information about a food additive which is necessary for its re-evaluation, in particular toxicological data and data relevant for the estimation of the human exposure to the relevant food additive, should be submitted by the interested parties to EFSA within the set time limits. |
| --- | --- |

(11)

EFSA should make public one or more open calls for data on all food additives to be re-evaluated. Any technical and scientific information about a food additive which is necessary for its re-evaluation, in particular toxicological data and data relevant for the estimation of the human exposure to the relevant food additive, should be submitted by the interested parties to EFSA within the set time limits.

| (12) | The food additives to be re-evaluated by EFSA have been previously assessed for their safety by the SCF and many of them have been used since long time. The information to be submitted for their re-evaluation should include existing data on which the previous evaluation of a food additive was based and any new data relevant to the food additive made available since its last evaluation by the SCF. That information should be as comprehensive as possible in order to allow EFSA to complete its re-evaluation and form an up-to-date opinion and should be submitted following to the extent possible the applicable guidance on submissions for food additive evaluations (currently the guidance established by the SCF on 11 July 2001 (5)). |
| --- | --- |

(12)

The food additives to be re-evaluated by EFSA have been previously assessed for their safety by the SCF and many of them have been used since long time. The information to be submitted for their re-evaluation should include existing data on which the previous evaluation of a food additive was based and any new data relevant to the food additive made available since its last evaluation by the SCF. That information should be as comprehensive as possible in order to allow EFSA to complete its re-evaluation and form an up-to-date opinion and should be submitted following to the extent possible the applicable guidance on submissions for food additive evaluations (currently the guidance established by the SCF on 11 July 2001 (5)).

| (13) | EFSA may require additional information in order to complete the re-evaluation of a food additive. In that case EFSA should request the necessary data in good time either by an open call for data or by contacting the parties that submitted data on the food additive. The interested parties should submit the requested information within a time period that is set by EFSA having considered, where relevant, the views of the interested parties. |
| --- | --- |

(13)

EFSA may require additional information in order to complete the re-evaluation of a food additive. In that case EFSA should request the necessary data in good time either by an open call for data or by contacting the parties that submitted data on the food additive. The interested parties should submit the requested information within a time period that is set by EFSA having considered, where relevant, the views of the interested parties.

| (14) | Regulation (EC) No 1333/2008 provides that the approval of food additives should also take into account environmental factors. Therefore, in the framework of the re-evaluation of a food additive the interested parties should inform the Commission and EFSA of any information relevant to any environmental risks from the production, use or waste of that additive. |
| --- | --- |

(14)

Regulation (EC) No 1333/2008 provides that the approval of food additives should also take into account environmental factors. Therefore, in the framework of the re-evaluation of a food additive the interested parties should inform the Commission and EFSA of any information relevant to any environmental risks from the production, use or waste of that additive.

| (15) | Where the requested information necessary for the completion of the re-evaluation of a particular food additive is not provided, the food additive may be removed from the Union list of approved food additives. |
| --- | --- |

(15)

Where the requested information necessary for the completion of the re-evaluation of a particular food additive is not provided, the food additive may be removed from the Union list of approved food additives.

| (16) | The re-evaluation procedure of food additives must fulfil transparency and public information requirements while guaranteeing the confidentiality of certain information. |
| --- | --- |

(16)

The re-evaluation procedure of food additives must fulfil transparency and public information requirements while guaranteeing the confidentiality of certain information.

| (17) | By the date of entry into force of this Regulation, the Commission will make available to the public a list of approved food additives that are being re-evaluated with the date of their latest evaluation by the ‘SCF’ or EFSA. |
| --- | --- |

(17)

By the date of entry into force of this Regulation, the Commission will make available to the public a list of approved food additives that are being re-evaluated with the date of their latest evaluation by the ‘SCF’ or EFSA.

| (18) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council opposed them, |
| --- | --- |

(18)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council opposed them,

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter and scope

1.   This Regulation sets up a programme for the re-evaluation by the European Food Safety Authority (hereinafter referred to as ‘EFSA’) of approved food additives, as provided for in Article 32 of Regulation (EC) No 1333/2008.

2.   Approved food additives, for which the re-evaluation by EFSA is already completed at the time of the adoption of this Regulation, shall not be re-evaluated again. Those food additives are listed in Annex I.

Article 2

Definitions

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

| (a) | ‘approved food additive’ means a food additive authorised before 20 January 2009 and listed in Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs (6), Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs (7) or in Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners (8); |
| --- | --- |

(a)

‘approved food additive’ means a food additive authorised before 20 January 2009 and listed in Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs (6), Directive 94/36/EC of the European Parliament and of the Council of 30 June 1994 on colours for use in foodstuffs (7) or in Directive 95/2/EC of the European Parliament and of the Council of 20 February 1995 on food additives other than colours and sweeteners (8);

| (b) | ‘business operator’ means any natural or legal person responsible for ensuring that the requirements of Regulation (EC) No 1333/2008 are met within the food business under its control; |
| --- | --- |

(b)

‘business operator’ means any natural or legal person responsible for ensuring that the requirements of Regulation (EC) No 1333/2008 are met within the food business under its control;

| (c) | ‘interested business operator’ means a business operator interested in the continuity of the authorisation of one or more approved food additives; |
| --- | --- |

(c)

‘interested business operator’ means a business operator interested in the continuity of the authorisation of one or more approved food additives;

| (d) | ‘original dossier’ means a dossier on the basis of which the food additive was evaluated and permitted for use in food before 20 January 2009. |
| --- | --- |

(d)

‘original dossier’ means a dossier on the basis of which the food additive was evaluated and permitted for use in food before 20 January 2009.

Article 3

Priorities for the re-evaluation of approved food additives

1.   Approved food additives shall be re-evaluated in the following order and within the following deadlines:

| (a) | the re-evaluation of all approved food colours listed in Directive 94/36/EC shall be completed by 31 December 2015; |
| --- | --- |

(a)

the re-evaluation of all approved food colours listed in Directive 94/36/EC shall be completed by 31 December 2015;

| (b) | the re-evaluation of all approved food additives other than colours and sweeteners listed in Directive 95/2/EC shall be completed by 31 December 2018; |
| --- | --- |

(b)

the re-evaluation of all approved food additives other than colours and sweeteners listed in Directive 95/2/EC shall be completed by 31 December 2018;

| (c) | the re-evaluation of all approved sweeteners listed in Directive 94/35/EC shall be completed by 31 December 2020. |
| --- | --- |

(c)

the re-evaluation of all approved sweeteners listed in Directive 94/35/EC shall be completed by 31 December 2020.

2.   For certain food additives within the functional classes referred to in paragraph 1 more specific deadlines are set out in Annex II to this Regulation. Those food additives shall be evaluated first among the other food additives of the same functional class.

3.   By way of derogation from paragraphs 1 and 2, EFSA may at any moment start the re-evaluation of a food additive or a group of food additives with priority, on a request from the Commission or on its own initiative, if new scientific evidence emerges that

| (a) | indicates a possible risk for human health or |
| --- | --- |

(a)

indicates a possible risk for human health or

| (b) | may in any way affect the safety assessment of that food additive or group of food additives. |
| --- | --- |

(b)

may in any way affect the safety assessment of that food additive or group of food additives.

Article 4

Re-evaluation procedure

When re-evaluating an approved food additive, EFSA shall:

| (a) | examine the original opinion and the working documents of the Scientific Committee on Food (‘SCF’) or EFSA; |
| --- | --- |

(a)

examine the original opinion and the working documents of the Scientific Committee on Food (‘SCF’) or EFSA;

| (b) | examine, where available, the original dossier; |
| --- | --- |

(b)

examine, where available, the original dossier;

| (c) | examine the data submitted by the interested business operator(s) and/or any other interested party; |
| --- | --- |

(c)

examine the data submitted by the interested business operator(s) and/or any other interested party;

| (d) | examine any data made available by the Commission and Member States; |
| --- | --- |

(d)

examine any data made available by the Commission and Member States;

| (e) | identify any relevant literature published since the last evaluation of each food additive. |
| --- | --- |

(e)

identify any relevant literature published since the last evaluation of each food additive.

Article 5

Call for data

1.   In order to acquire the data from the interested business operators and/or other interested parties, EFSA shall make open call(s) for data for the food additives under re-evaluation. In specifying the timetable for data submission, EFSA shall allow a reasonable time period after the entry into force of this Regulation, to allow the interested business operator and/or any other interested party to meet this duty.

2.   The data referred to in paragraph 1 may comprise among others:

| (a) | study reports from the original dossier as evaluated by the SCF or EFSA or the Joint FAO/WHO Expert Committee on Food Additives (JECFA), |
| --- | --- |

(a)

study reports from the original dossier as evaluated by the SCF or EFSA or the Joint FAO/WHO Expert Committee on Food Additives (JECFA),

| (b) | information on the data on the safety of the food additive concerned not previously reviewed by the SCF or the JECFA, |
| --- | --- |

(b)

information on the data on the safety of the food additive concerned not previously reviewed by the SCF or the JECFA,

| (c) | information on the specifications of the food additives presently in use, including information on particle size and relevant physicochemical characteristics and properties, |
| --- | --- |

(c)

information on the specifications of the food additives presently in use, including information on particle size and relevant physicochemical characteristics and properties,

| (d) | information on the manufacturing process, |
| --- | --- |

(d)

information on the manufacturing process,

| (e) | information on analytical methods available for determination in food, |
| --- | --- |

(e)

information on analytical methods available for determination in food,

| (f) | information on the human exposure to the food additives from food (e.g. consumption pattern and uses, actual use levels and maximum use levels, frequency of consumption and other factors influencing exposure), |
| --- | --- |

(f)

information on the human exposure to the food additives from food (e.g. consumption pattern and uses, actual use levels and maximum use levels, frequency of consumption and other factors influencing exposure),

| (g) | reaction and fate in food. |
| --- | --- |

(g)

reaction and fate in food.

Article 6

Submission of data

1.   The interested business operator(s) and any other interested party shall submit the data related to the re-evaluation of a food additive as referred to in Article 5(2), within the period set by EFSA in its call for data. In the submission the interested business operator and the other interested parties shall include the data requested by EFSA by following, to the extent possible, the applicable guidance on submissions for food additive evaluations (9).

2.   Where there are several interested business operators they may, when possible, submit the data collectively.

3.   If during the re-evaluation additional information considered to be relevant for the re-evaluation of a particular food additive is needed, EFSA shall request from the interested business operators, and shall invite other interested parties, to submit this information by an open call for data. It shall set a deadline within which that information shall be submitted having considered, where relevant, the interested business operator's and/or other interested parties' view of the time required. In such cases, EFSA shall make the request for the additional information well in advance so that the overall deadlines for the re-evaluation as set out in Article 3(1) and in Annex II are not affected.

4.   Information which has not been submitted within the deadline set by EFSA shall not be taken into account in the re-evaluation. However, in exceptional cases, EFSA may decide with the agreement of the Commission to take into account information submitted after the deadline, if that information is significant for the re-evaluation of a food additive.

5.   Where the requested information has not been submitted to EFSA within the set deadlines, the food additive may be removed from the Union list in accordance with the procedure laid down in Article 10.3 of Regulation (EC) No 1333/2008 (10).

Article 7

Other information

In the framework of the re-evaluation of a food additive, the interested business operator(s) or any other interested party shall inform EFSA and the Commission of any information available in relation to any environment risks from the production, use or waste of that food additive.

Article 8

Confidentiality

1.   Confidential treatment may be given to information the disclosure of which might significantly harm the competitive position of business operators or other interested parties.

2.   Information relating to the following shall not, in any circumstances, be regarded as confidential:

| (a) | the name and address of the interested business operator; |
| --- | --- |

(a)

the name and address of the interested business operator;

| (b) | the chemical name and a clear description of the substance; |
| --- | --- |

(b)

the chemical name and a clear description of the substance;

| (c) | information for the use of the substance in or on specific foodstuffs or food categories; |
| --- | --- |

(c)

information for the use of the substance in or on specific foodstuffs or food categories;

| (d) | information that is relevant to the assessment of the safety of the substance; |
| --- | --- |

(d)

information that is relevant to the assessment of the safety of the substance;

| (e) | the method(s) of analysis in food. |
| --- | --- |

(e)

the method(s) of analysis in food.

3.   For the purposes of paragraph 1, the interested business operator(s) and the other interested parties shall indicate which of the information provided they wish to be treated as confidential. Verifiable justification shall be given in such cases.

4.   On a proposal from EFSA, the Commission shall decide after consulting the interested business operator and/or the other interested parties which information may remain confidential and shall notify the EFSA and the Member States accordingly.

5.   The Commission, EFSA and the Member States shall, in accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (11), take the necessary measures to ensure appropriate confidentiality of the information received under this Regulation, except for information which must be made public if circumstances so require in order to protect human health, animal health or the environment.

6.   The implementation of paragraphs 1 to 5 shall not affect the circulation of information between the Commission, EFSA and the Member States.

Article 9

Monitoring progress

Every year in December, EFSA shall inform the Commission and the Member States on the progress of the re-evaluation programme.

Article 10

Entry into force

This Regulation shall enter into force on the twentieth day following that 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, 25 March 2010.

For the Commission

The President

José Manuel BARROSO

---

(1)  OJ L 354, 31.12.2008, p. 16.

1

(2)  COM(2007) 418 final.

2

(3)  COM(2001) 542 final.

3

(4)  Food Additives in Europe 2000, Status of safety assessments of food additives presently permitted in the EU, Nordic Council of Ministers, TemaNord 2002:560.

4

(5)  Guidance on submissions for food additive evaluations by the Scientific Committee on Food. Opinion expressed on 11 July 2001. SCF/CS/ADD/GEN/26 final.

5

(6)  OJ L 237, 10.9.1994, p. 3.

6

(7)  OJ L 237, 10.9.1994, p. 13.

7

(8)  OJ L 61, 18.3.1995, p. 1.

8

(9)  Currently the Opinion expressed by the SCF on 11 July 2001. SCF/CS/ADD/GEN/26 Final.

9

(10)  OJ L 354, 31.12.2008, p. 16.

10

(11)  OJ L 145, 31.5.2001, p. 43.

11

---

ANNEX I

A list of approved food additives which were approved before 20 January 2009 and for which the re-evaluation by EFSA is completed at the time of adoption of this Regulation

| E No | Substance | Year of latest evaluation by SCF or EFSA | Status of re-evaluation by EFSA |
| --- | --- | --- | --- |
| E 102 | Tartrazine | 2009 | Re-evaluation completed on 23 September 2009 |
| E 104 | Quinoline Yellow | 2009 | Re-evaluation completed on 23 September 2009 |
| E 110 | Sunset yellow FCF, Orange Yellow S | 2009 | Re-evaluation completed on 24 September 2009 |
| E 122 | Azorubine, Carmoisine | 2009 | Re-evaluation completed on 24 September 2009 |
| E 124 | Ponceau 4R, Cochineal Red A | 2009 | Re-evaluation completed on 23 September 2009 |
| E 129 | Allura Red AC | 2009 | Re-evaluation completed on 23 September 2009 |
| E 160d | Lycopene | 2008 | Re-evaluation completed on 30 January 2008 |
| E 234 | Nisin | 2006 | Re-evaluation completed on 26 January 2006 |
| E 173 | Aluminium | 2008 | Re-evaluation completed on 22 May 2008 |
| E 214 | Ethyl p-hydroxybenzoate | 2004 | Re-evaluation completed on 13 July 2004 |
| E 215 | Sodium ethyl p-hydroxybenzoate | 2004 | Re-evaluation completed on 13 July 2004 |
| E 218 | Methyl p-hydroxybenzoate | 2004 | Re-evaluation completed on 13 July 2004 |
| E 219 | Sodium methyl p-hydroxybenzoate | 2004 | Re-evaluation completed on 13 July 2004 |
| E 235 | Natamycin | 2009 | Re-evaluation completed on 26 November 2009 |
| E 473 | Sucrose esters of fatty acids | 2006 | Re-evaluation completed on 23 November 2004; revised on 26 January 2006 |
| E 474 | Sucroglycerides | 2006 | Re-evaluation completed on 23 November 2004; revised on 26 January 2006 |
| E 901 | Beeswax, white and yellow | 2007 | Re-evaluation completed on 27 November 2007 |

E No

Substance

Year of latest evaluation by SCF or EFSA

Status of re-evaluation by EFSA

E 102

Tartrazine

2009

Re-evaluation completed on 23 September 2009

E 104

Quinoline Yellow

2009

Re-evaluation completed on 23 September 2009

E 110

Sunset yellow FCF, Orange Yellow S

2009

Re-evaluation completed on 24 September 2009

E 122

Azorubine, Carmoisine

2009

Re-evaluation completed on 24 September 2009

E 124

Ponceau 4R, Cochineal Red A

2009

Re-evaluation completed on 23 September 2009

E 129

Allura Red AC

2009

Re-evaluation completed on 23 September 2009

E 160d

Lycopene

2008

Re-evaluation completed on 30 January 2008

E 234

Nisin

2006

Re-evaluation completed on 26 January 2006

E 173

Aluminium

2008

Re-evaluation completed on 22 May 2008

E 214

Ethyl p-hydroxybenzoate

2004

Re-evaluation completed on 13 July 2004

E 215

Sodium ethyl p-hydroxybenzoate

2004

Re-evaluation completed on 13 July 2004

E 218

Methyl p-hydroxybenzoate

2004

Re-evaluation completed on 13 July 2004

E 219

Sodium methyl p-hydroxybenzoate

2004

Re-evaluation completed on 13 July 2004

E 235

Natamycin

2009

Re-evaluation completed on 26 November 2009

E 473

Sucrose esters of fatty acids

2006

Re-evaluation completed on 23 November 2004; revised on 26 January 2006

E 474

Sucroglycerides

2006

Re-evaluation completed on 23 November 2004; revised on 26 January 2006

E 901

Beeswax, white and yellow

2007

Re-evaluation completed on 27 November 2007

---

ANNEX II

Specific priorities for certain food additives within the functional classes of food additives as referred to in Article 3(1) and (2)

PART I:   FOOD COLOURS

Within the overall deadline of 31.12.2015 set for the re-evaluation of food colours in Article 3(1) the following specific deadlines are set for the following food colours:

| 1. | The following food colours shall be evaluated by 15.4.2010







  E 123 | Amaranth, |
| --- | --- | --- |
| E 151 | Brilliant Black BN, Black PN |
| E 154 | Brown FK, |
| E 155 | Brown HT and |
| E 180 | Litholrubine BK |

1.

The following food colours shall be evaluated by 15.4.2010

E 123

Amaranth,

E 151

Brilliant Black BN, Black PN

E 154

Brown FK,

E 155

Brown HT and

E 180

Litholrubine BK

| 2. | The following food colours shall be evaluated by 31.12.2010







  E 100 | Curcumin, |
| --- | --- | --- |
| E 127 | Erythrosine, |
| E 131 | Patent Blue V, |
| E 132 | Indigotine, Indigo carmine |
| E 133 | Brilliant Blue FCF, |
| E 142 | Green S, |
| E 150a | Plain caramel, |
| E 150b | Caustic sulphite caramel, |
| E 150c | Ammonia caramel, |
| E 150d | Sulphite ammonia caramel, |
| E 161b | Lutein, |
| E 161g | Canthaxanthin, |
| E 170 | Calcium carbonate, |

2.

The following food colours shall be evaluated by 31.12.2010

E 100

Curcumin,

E 127

Erythrosine,

E 131

Patent Blue V,

E 132

Indigotine, Indigo carmine

E 133

Brilliant Blue FCF,

E 142

Green S,

E 150a

Plain caramel,

E 150b

Caustic sulphite caramel,

E 150c

Ammonia caramel,

E 150d

Sulphite ammonia caramel,

E 161b

Lutein,

E 161g

Canthaxanthin,

E 170

Calcium carbonate,

| 3. | The following food colours shall be evaluated by 31.12.2015







  E 101 | (i) Riboflavin (ii) Riboflavin-5’-phosphate, |
| --- | --- | --- |
| E 120 | Cochineal, Carminic acid, Carmines |
| E 140 | Chlorophylls and Chlorophyllins: (i) Chlorophylls (ii) Chlorophyllins, |
| E 141 | Copper complexes of Chlorophylls and Chlorophyllins: (i) Copper complexes of chlorophylls (ii) Copper complexes of chlorophyllins, |
| E 153 | Vegetable carbon, |
| E 160b | Annatto, bixin, norbixin |
| E 160a | Carotenes: (i) mixed carotenes, (ii) beta-carotene, |
| E 160c | Paprika extract, capsanthin, capsorubin, |
| E 160e | Beta-apo-8’-carotenal (C30), |
| E 160f | Ethyl ester of beta-apo-8’, -carotenoic acid (C30), |
| E 162 | Beetroot red, betanin, |
| E 163 | Anthocyanins, |
| E 171 | Titanium dioxide, |
| E 172 | Iron oxides and hydroxides, |
| E 174 | Silver, |
| E 175 | Gold |

3.

The following food colours shall be evaluated by 31.12.2015

E 101

(i) Riboflavin (ii) Riboflavin-5’-phosphate,

E 120

Cochineal, Carminic acid, Carmines

E 140

Chlorophylls and Chlorophyllins: (i) Chlorophylls (ii) Chlorophyllins,

E 141

Copper complexes of Chlorophylls and Chlorophyllins: (i) Copper complexes of chlorophylls (ii) Copper complexes of chlorophyllins,

E 153

Vegetable carbon,

E 160b

Annatto, bixin, norbixin

E 160a

Carotenes: (i) mixed carotenes, (ii) beta-carotene,

E 160c

Paprika extract, capsanthin, capsorubin,

E 160e

Beta-apo-8’-carotenal (C30),

E 160f

Ethyl ester of beta-apo-8’, -carotenoic acid (C30),

E 162

Beetroot red, betanin,

E 163

Anthocyanins,

E 171

Titanium dioxide,

E 172

Iron oxides and hydroxides,

E 174

Silver,

E 175

Gold

PART II:   FOOD ADDITIVES OTHER THAN COLOURS AND SWEETENERS

Within the overall deadline of 31.12.2018 set for the re-evaluation of food additives other than colours and sweeteners in Article 3(1), the following specific deadlines are set for certain food additives and groups of food additives:

| 1. | Preservatives and antioxidants E 200-203; E 210-215, E 218-252, E 280-285; E 300-E 321 and E 586 shall be evaluated by 31.12.2015

  with higher priority within this group on:






  E 310-312 | Gallates |
| --- | --- | --- |
| E 320 | Butylated hydroxyanisole (BHA) |
| E 321 | Butylated hydroxytoluene (BHT) |
| E 220-228 | Sulphur dioxide and sulphites |
| E 304 | Fatty acid esters of ascorbic acid: (i) Ascorbyl palmitate (ii) Ascorbyl stearate |
| E 200-203 | Sorbic acid and sorbates |
| E 284 | Boric acid |
| E 285 | Sodium tetraborate (borax) |
| E 239 | Hexamethylene tetramine |
| E 242 | Dimethyl dicarbonate |
| E 249 | Potassium nitrite |
| E 250 | Sodium nitrite |
| E 251 | Sodium nitrate |
| E 252 | Potassium nitrate |
| E 280-283 | Propionic acid and its sodium, calcium and potassium salts |
| E 306 | Tocopherol-rich extract |
| E 307 | Alpha-tocopherol |
| E 308 | Gamma-tocopherol |
| E 309 | Delta-tocopherol |

1.

Preservatives and antioxidants E 200-203; E 210-215, E 218-252, E 280-285; E 300-E 321 and E 586 shall be evaluated by 31.12.2015

with higher priority within this group on:

E 310-312

Gallates

E 320

Butylated hydroxyanisole (BHA)

E 321

Butylated hydroxytoluene (BHT)

E 220-228

Sulphur dioxide and sulphites

E 304

Fatty acid esters of ascorbic acid: (i) Ascorbyl palmitate (ii) Ascorbyl stearate

E 200-203

Sorbic acid and sorbates

E 284

Boric acid

E 285

Sodium tetraborate (borax)

E 239

Hexamethylene tetramine

E 242

Dimethyl dicarbonate

E 249

Potassium nitrite

E 250

Sodium nitrite

E 251

Sodium nitrate

E 252

Potassium nitrate

E 280-283

Propionic acid and its sodium, calcium and potassium salts

E 306

Tocopherol-rich extract

E 307

Alpha-tocopherol

E 308

Gamma-tocopherol

E 309

Delta-tocopherol

| 2. | Emulsifiers, stabilisers, gelling agents E 322, E 400-E 419; E 422-E 495; E 1401-E 1451 shall be evaluated by 31.12.2016

  With higher priority within this group on:






  E 483 | Stearyl tartrate |
| --- | --- | --- |
| E 491-495 | Sorbitan esters |
| E 431 | Polyoxyethylene (40) stearate |
| E 432-436 | Polysorbates |
| E 444 | Sucrose acetate isobutyrate |
| E 481 | Sodium stearoyl-2-lactylate |
| E 482 | Calcium stearoyl-2-lactylate |
| E 414 | Acacia gum (gum arabic) (1) |
| E 410 | Locust bean gum (1) |
| E 417 | Tara gum (1) |
| E 422 | Glycerol |
| E 475 | Polyglycerol esters of fatty acids |

2.

Emulsifiers, stabilisers, gelling agents E 322, E 400-E 419; E 422-E 495; E 1401-E 1451 shall be evaluated by 31.12.2016

With higher priority within this group on:

E 483

Stearyl tartrate

E 491-495

Sorbitan esters

E 431

Polyoxyethylene (40) stearate

E 432-436

Polysorbates

E 444

Sucrose acetate isobutyrate

E 481

Sodium stearoyl-2-lactylate

E 482

Calcium stearoyl-2-lactylate

E 414

Acacia gum (gum arabic) (1)

E 410

Locust bean gum (1)

E 417

Tara gum (1)

E 422

Glycerol

E 475

Polyglycerol esters of fatty acids

| 3. | E 551 Silicon dioxide, E 620-625 Glutamates, E 1105 Lysozyme and E 1103 Invertase shall be evaluated by 31.12.2016 |
| --- | --- |

3.

E 551 Silicon dioxide, E 620-625 Glutamates, E 1105 Lysozyme and E 1103 Invertase shall be evaluated by 31.12.2016

| 4. | The remaining food additives other than colours and sweeteners shall be evaluated by 31.12.2018

  With higher priority on






  E 552 | Calcium silicate |
| --- | --- | --- |
| E 553a | Magnesium silicate and trisilicate |
| E 553b | Talc |
| E 558 | Bentonite |
| E 999 | Quillaia extract |
| E 338-343 | Phosphoric acid and phosphates |
| E 450-452 | Di-, tri- and polyphosphates |
| E 900 | Dimethyl polysiloxane |
| E 912 | Montan acid esters |
| E 914 | Oxidised polyethylene wax |
| E 902 | Candellila wax |
| E 904 | Shellac |
| E 626-629 | Guanylic acid, Disodium guanylate, Dipotassium guanylate and Calcium guanylate |
| E 630-633 | Inosinic acid, Disodium inosinate; Dipotassium inosinate and Calcium inosinate |
| E 634-635 | Calcium 5'-ribonucleotides and Disodium 5'-ribonucleotides |
| E 507-511 | Hydrochloric acid, Potassium chloride, Calcium chloride, Magnesium chloride |
| E 513 | Sulphuric acid |

4.

The remaining food additives other than colours and sweeteners shall be evaluated by 31.12.2018

With higher priority on

E 552

Calcium silicate

E 553a

Magnesium silicate and trisilicate

E 553b

Talc

E 558

Bentonite

E 999

Quillaia extract

E 338-343

Phosphoric acid and phosphates

E 450-452

Di-, tri- and polyphosphates

E 900

Dimethyl polysiloxane

E 912

Montan acid esters

E 914

Oxidised polyethylene wax

E 902

Candellila wax

E 904

Shellac

E 626-629

Guanylic acid, Disodium guanylate, Dipotassium guanylate and Calcium guanylate

E 630-633

Inosinic acid, Disodium inosinate; Dipotassium inosinate and Calcium inosinate

E 634-635

Calcium 5'-ribonucleotides and Disodium 5'-ribonucleotides

E 507-511

Hydrochloric acid, Potassium chloride, Calcium chloride, Magnesium chloride

E 513

Sulphuric acid

---

(1)  All natural gums E 400-418 and E 425 could be evaluated at the same time.

---

| 26.3.2010 | EN | Official Journal of the European Union | L 80/28 |
| --- | --- | --- | --- |

26.3.2010

EN

Official Journal of the European Union

L 80/28

---

COMMISSION REGULATION (EU) No 258/2010

of 25 March 2010

imposing special conditions on the imports of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxins, and repealing Decision 2008/352/EC

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 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 (1), and in particular Article 53(1)(b)(ii) thereof,

Whereas:

| (1) | Article 53(1) of Regulation (EC) No 178/2002 provides for the possibility to adopt appropriate emergency measures for food and feed imported from a third country in order to protect public health, animal health or the environment, where the risk cannot be contained satisfactorily by means of measures taken by the Member States individually. |
| --- | --- |

(1)

Article 53(1) of Regulation (EC) No 178/2002 provides for the possibility to adopt appropriate emergency measures for food and feed imported from a third country in order to protect public health, animal health or the environment, where the risk cannot be contained satisfactorily by means of measures taken by the Member States individually.

| (2) | In July 2007, high levels of pentachlorophenol (PCP) and dioxins have been found in the EU in certain batches of guar gum originating in or consigned from India. Such contamination constitutes a threat to public health within the European Union if no measures are taken to avoid the presence of pentachlorophenol and dioxins in guar gum. |
| --- | --- |

(2)

In July 2007, high levels of pentachlorophenol (PCP) and dioxins have been found in the EU in certain batches of guar gum originating in or consigned from India. Such contamination constitutes a threat to public health within the European Union if no measures are taken to avoid the presence of pentachlorophenol and dioxins in guar gum.

| (3) | In response to this finding of elevated levels of PCP and dioxins, the Food and Veterinary Office of the European Commission (FVO) carried out an urgent inspection visit to India in October 2007. The objective was to gather information on the possible source of the contamination and to assess the control measures put in place by the Indian authorities to avoid the re-occurrence of this contamination. The inspection team concluded that there was insufficient evidence of the cause of the contamination incident, and the investigation carried out by the Indian authorities was inadequate to provide any conclusions. With availability of sodium pentachlorophenolate and its use in the guar gum industry, and with a largely self regulated industry, there were inadequate controls in place to ensure that this contamination does not occur again. |
| --- | --- |

(3)

In response to this finding of elevated levels of PCP and dioxins, the Food and Veterinary Office of the European Commission (FVO) carried out an urgent inspection visit to India in October 2007. The objective was to gather information on the possible source of the contamination and to assess the control measures put in place by the Indian authorities to avoid the re-occurrence of this contamination. The inspection team concluded that there was insufficient evidence of the cause of the contamination incident, and the investigation carried out by the Indian authorities was inadequate to provide any conclusions. With availability of sodium pentachlorophenolate and its use in the guar gum industry, and with a largely self regulated industry, there were inadequate controls in place to ensure that this contamination does not occur again.

| (4) | Therefore, Commission Decision 2008/352/EC of 29 April 2008 imposing special conditions governing guar gum originating in or consigned from India due to contamination risks of those products by pentachlorophenol and dioxins (2) provides that each consignment of guar gum and compound feedingstuffs and foodstuffs containing at least 10 % guar gum originating in or consigned from India, has to be accompanied by an original analytical report, endorsed by a representative of the competent authority from the country where the laboratory is located, demonstrating that the product does not contain more than 0,01 mg/kg PCP. The competent authorities in the Member States have to sample and analyse consignments of these products with a frequency of 5 % in order to verify that the level of 0,01 mg/kg PCP is not exceeded. The Community Reference Laboratory for Dioxins and PCBs in Feed and Food has carried out a study on the correlation between PCP and dioxins in contaminated guar gum from India. From this study it can be concluded that guar gum containing a level of PCP below the level of 0,01 mg/kg does not contain unacceptable levels of dioxins. |
| --- | --- |

(4)

Therefore, Commission Decision 2008/352/EC of 29 April 2008 imposing special conditions governing guar gum originating in or consigned from India due to contamination risks of those products by pentachlorophenol and dioxins (2) provides that each consignment of guar gum and compound feedingstuffs and foodstuffs containing at least 10 % guar gum originating in or consigned from India, has to be accompanied by an original analytical report, endorsed by a representative of the competent authority from the country where the laboratory is located, demonstrating that the product does not contain more than 0,01 mg/kg PCP. The competent authorities in the Member States have to sample and analyse consignments of these products with a frequency of 5 % in order to verify that the level of 0,01 mg/kg PCP is not exceeded. The Community Reference Laboratory for Dioxins and PCBs in Feed and Food has carried out a study on the correlation between PCP and dioxins in contaminated guar gum from India. From this study it can be concluded that guar gum containing a level of PCP below the level of 0,01 mg/kg does not contain unacceptable levels of dioxins.

| (5) | A follow-up inspection mission of the FVO took place in October 2009 to assess the control measures put in place by the Indian authorities to prevent contamination of guar gum with PCP and dioxins and to follow-up the recommendations of the mission that took place in October 2007. |
| --- | --- |

(5)

A follow-up inspection mission of the FVO took place in October 2009 to assess the control measures put in place by the Indian authorities to prevent contamination of guar gum with PCP and dioxins and to follow-up the recommendations of the mission that took place in October 2007.

| (6) | Several serious deficiencies were observed during that inspection mission. The status of PCP in industrial use in India is not clear and at the time of the mission no evidence of any action being taken to stop its production or sale was presented. Samples are taken by the exporting private company without any official supervision. Non-conformities found by the laboratory at a frequency of about 2,5 % of samples analysed are notified to the exporting company without notifying the competent authority. As there was no knowledge on the part of the competent authority of these non-compliances, no action was taken regarding the non-conforming lots. |
| --- | --- |

(6)

Several serious deficiencies were observed during that inspection mission. The status of PCP in industrial use in India is not clear and at the time of the mission no evidence of any action being taken to stop its production or sale was presented. Samples are taken by the exporting private company without any official supervision. Non-conformities found by the laboratory at a frequency of about 2,5 % of samples analysed are notified to the exporting company without notifying the competent authority. As there was no knowledge on the part of the competent authority of these non-compliances, no action was taken regarding the non-conforming lots.

| (7) | The findings indicate that the contamination of guar gum with PCP and/or dioxins cannot be regarded as an isolated incident and that only the effective analysis by the approved private laboratory has prevented contaminated product being further exported to the European Union. Taking into account that there has been no improvement in the control system additional measures should be taken in order to reduce possible risks. |
| --- | --- |

(7)

The findings indicate that the contamination of guar gum with PCP and/or dioxins cannot be regarded as an isolated incident and that only the effective analysis by the approved private laboratory has prevented contaminated product being further exported to the European Union. Taking into account that there has been no improvement in the control system additional measures should be taken in order to reduce possible risks.

| (8) | Given that it cannot be excluded that guar gum originating in India is exported to the EU via another third country, it is appropriate to foresee random controls on the presence of PCP in guar gum consigned from countries other than India. |
| --- | --- |

(8)

Given that it cannot be excluded that guar gum originating in India is exported to the EU via another third country, it is appropriate to foresee random controls on the presence of PCP in guar gum consigned from countries other than India.

| (9) | Therefore, Decision 2008/352/EC should be amended accordingly. However, taking into account the nature of the amending provisions, which have a direct application and are binding in their entirety, it is appropriate to replace that Decision with a Regulation. |
| --- | --- |

(9)

Therefore, Decision 2008/352/EC should be amended accordingly. However, taking into account the nature of the amending provisions, which have a direct application and are binding in their entirety, it is appropriate to replace that Decision with a Regulation.

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

(10)

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

Scope

This Regulation shall apply to:

| (a) | guar gum, falling within CN code 1302 32 90, originating in or consigned from India, and intended for animal or human consumption; |
| --- | --- |

(a)

guar gum, falling within CN code 1302 32 90, originating in or consigned from India, and intended for animal or human consumption;

| (b) | feed and food containing at least 10 % guar gum originating in or consigned from India. |
| --- | --- |

(b)

feed and food containing at least 10 % guar gum originating in or consigned from India.

Article 2

Certification

1.   Each consignment of the products referred to in Article 1 presented for import shall be accompanied by:

| (a) | a health certificate, provided in the Annex, certifying that the product imported does not contain more than 0,01 mg/kg pentachlorophenol (PCP) and |
| --- | --- |

(a)

a health certificate, provided in the Annex, certifying that the product imported does not contain more than 0,01 mg/kg pentachlorophenol (PCP) and

| (b) | an analytical report, issued by a laboratory accredited according to EN ISO/IEC 17025 for the analysis of PCP in feed and food, indicating the results of sampling and analysis for the presence of PCP, the measurement uncertainty of the analytical result, as well as the limit of detection (LOD) and the limit of quantification (LOQ) of the analytical method. |
| --- | --- |

(b)

an analytical report, issued by a laboratory accredited according to EN ISO/IEC 17025 for the analysis of PCP in feed and food, indicating the results of sampling and analysis for the presence of PCP, the measurement uncertainty of the analytical result, as well as the limit of detection (LOD) and the limit of quantification (LOQ) of the analytical method.

2.   The certificate accompanied by an analytical report shall be signed by an authorised representative of the Ministry of Commerce and Industry of India and the validity of the certificate shall not exceed 4 months from the date of its issue.

3.   The analysis referred to in paragraph 1(b) must be performed on a sample, taken by the competent Indian authorities from the consignment in accordance with the provisions of Commission Directive 2002/63/EC of 11 July 2002 establishing Community methods of sampling for the official control of pesticide residues in and on products of plant and animal origin and repealing Directive 79/700/EEC (3). The extraction before analysis shall be performed with an acidified solvent. The analysis shall be carried out according to the modified version of the QuEChERS method as set out on the website of the Community Reference Laboratories for Residues of Pesticides (4) or according to an equally reliable method.

Article 3

Identification

Each consignment of the products referred to in Article 1 shall be identified by means of a code which shall be indicated on the health certificate, on the analytical report containing the results of sampling and analysis, and on any commercial documents accompanying the consignment. Each individual bag or other packaging form of the consignment shall be identified with that code.

Article 4

Prior notification

Feed and food business operators or their representatives shall give prior notification to the control point referred to in Article 5(4) of the estimated date and time of arrival of all consignments of products referred to in Article 1.

Article 5

Official controls

1.   The competent authorities of the Member States shall carry out documentary, identity and physical checks, including laboratory analysis on the consignments of products referred to in Article 1.

2.   Identity and physical checks, including sampling and analysis to control the presence of PCP, shall be carried out on at least 5 % of the consignments.

3.   Consignments shall be kept under official control for a maximum of 15 working days pending the availability of the results of the laboratory analysis.

4.   The checks referred to in paragraph 1 shall be carried out at control points specifically designated by the Member States for that purpose.

5.   Member States shall make the list of control points available to the public and communicate it to the Commission.

6.   The competent authorities of the Member States shall also perform at random physical checks, including sampling and analysis to control the presence of PCP on guar gum consigned from countries other than India.

Article 6

Splitting of a consignment

Consignments shall not be split until all official controls have been completed. If a consignment is split, a certified copy of the health certificate provided for in Article 2(1)(a), shall accompany each part of the split consignment until its release into free circulation.

Article 7

Costs

All costs resulting from the official controls referred to in Article 5(1), including sampling, analysis, storage and any measures taken following non-compliance, shall be borne by the feed and food business operator.

Article 8

Release into free circulation

The release into 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 the evidence that:

| (a) | the official controls referred to in Article 5(1) have been carried out and |
| --- | --- |

(a)

the official controls referred to in Article 5(1) have been carried out and

| (b) | the results from physical checks, where such checks were required, have been favourable. |
| --- | --- |

(b)

the results from physical checks, where such checks were required, have been favourable.

Article 9

Non-compliant products

Any product found to contain more than 0,01 mg/kg PCP, taking into account the expanded measurement uncertainty, following controls performed in accordance with Article 5, shall not enter the feed and food chain. The non-compliant products shall be safely disposed of, in accordance with the provisions of Article 19 of 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 (5).

Article 10

Reports

Member States shall inform the Commission through the Rapid Alert System for Food and Feed (RASFF) of all consignments which are found to contain PCP above 0,01 mg/kg taking into account the expanded measurement uncertainty.

Member States shall submit to the Commission every three months a report on all analytical results of the controls referred to in Article 5(1). Those reports shall be submitted during the month following each quarter.

Article 11

Repeal

Commission Decision 2008/352/EC is repealed.

References to the repealed Decision shall be construed as references to this Regulation.

Article 12

Transitional provisions

By way of derogation from Article 2(1), Member States shall authorise the imports of consignments of products referred to in Article 1 which left the country of origin before 1 April 2010 accompanied by an analytical report as provided for by Decision 2008/352/EC.

Article 13

Entry into force

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

It shall apply from the date of entry into force.

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

Done at Brussels, 25 March 2010.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  OJ L 117, 1.5.2008, p. 42.

2

(3)  OJ L 187, 16.7.2002, p. 30.

3

(4)  http://www.crl-pesticides.eu/library/docs/srm/QuechersForGuarGum.pdf

4

(5)  OJ L 191, 28.5.2004, p. 1.

5

---

ANNEX

Image

---

| 26.3.2010 | EN | Official Journal of the European Union | L 80/32 |
| --- | --- | --- | --- |

26.3.2010

EN

Official Journal of the European Union

L 80/32

---

COMMISSION REGULATION (EU) No 259/2010

of 25 March 2010

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

THE EUROPEAN COMMISSION,

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

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

Whereas:

| (1) | Pursuant to the first subparagraph of Article 6(2) and in accordance with Article 17(2) of Regulation (EC) No 510/2006, Italy’s application to register the name ‘Colline Pontine’ was published in the Official Journal of the European Union
   (2). |
| --- | --- |

(1)

Pursuant to the first subparagraph of Article 6(2) and in accordance with Article 17(2) of Regulation (EC) No 510/2006, Italy’s application to register the name ‘Colline Pontine’ was 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, that 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, that name should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name contained in the Annex to this Regulation is hereby 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, 25 March 2010.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  OJ C 197, 21.8.2009, p. 14.

2

---

ANNEX

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

Class 1.5.   Oils and fats (butter, margarine, oils, etc.)

ITALY

Colline Pontine (PDO)

---

| 26.3.2010 | EN | Official Journal of the European Union | L 80/34 |
| --- | --- | --- | --- |

26.3.2010

EN

Official Journal of the European Union

L 80/34

---

COMMISSION REGULATION (EU) No 260/2010

of 25 March 2010

entering a name in the register of protected designations of origin and protected geographical indications (Chirimoya de la Costa tropical de Granada-Málaga (PDO))

THE EUROPEAN COMMISSION,

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

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

Whereas:

| (1) | Pursuant to the first subparagraph of Article 6(2) and in accordance with Article 17(2) of Regulation (EC) No 510/2006, Spain’s application to register the name ‘Chirimoya de la Costa tropical de Granada-Málaga’ was published in the Official Journal of the European Union
   (2). |
| --- | --- |

(1)

Pursuant to the first subparagraph of Article 6(2) and in accordance with Article 17(2) of Regulation (EC) No 510/2006, Spain’s application to register the name ‘Chirimoya de la Costa tropical de Granada-Málaga’ was published in the Official Journal of the European Union
   (2).

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

(2)

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

HAS ADOPTED THIS REGULATION:

Article 1

The name contained in the Annex to this Regulation is hereby 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, 25 March 2010.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  OJ C 197, 21.8.2009, p. 10.

2

---

ANNEX

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

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

SPAIN

Chirimoya de la Costa tropical de Granada-Málaga (PDO)

---

| 26.3.2010 | EN | Official Journal of the European Union | L 80/36 |
| --- | --- | --- | --- |

26.3.2010

EN

Official Journal of the European Union

L 80/36

---

COMMISSION REGULATION (EU) No 261/2010

of 25 March 2010

amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (1), and in particular Article 12 thereof,

Whereas:

| (1) | According to Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (2), the revenue of the European Medicines Agency (hereinafter the Agency) consists of a contribution from the Union and fees paid by undertakings to the Agency. Regulation (EC) No 297/95 lays down the categories and levels of such fees. |
| --- | --- |

(1)

According to Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (2), the revenue of the European Medicines Agency (hereinafter the Agency) consists of a contribution from the Union and fees paid by undertakings to the Agency. Regulation (EC) No 297/95 lays down the categories and levels of such fees.

| (2) | Article 12 of Regulation (EC) No 297/95 requires that the fees of the Agency be updated each year by reference to the inflation rate. |
| --- | --- |

(2)

Article 12 of Regulation (EC) No 297/95 requires that the fees of the Agency be updated each year by reference to the inflation rate.

| (3) | Those fees should therefore be updated by reference to the inflation rate of 2009. The inflation rate in the Union, as published by the Statistical Office of the European Union (Eurostat), was 1 % in 2009. |
| --- | --- |

(3)

Those fees should therefore be updated by reference to the inflation rate of 2009. The inflation rate in the Union, as published by the Statistical Office of the European Union (Eurostat), was 1 % in 2009.

| (4) | For the sake of simplicity, the adjusted levels of the fees should be rounded to the nearest EUR 100. |
| --- | --- |

(4)

For the sake of simplicity, the adjusted levels of the fees should be rounded to the nearest EUR 100.

| (5) | Regulation (EC) No 297/95 should therefore be amended accordingly. |
| --- | --- |

(5)

Regulation (EC) No 297/95 should therefore be amended accordingly.

| (6) | For reasons of legal certainty, this Regulation should not apply to valid applications which are pending on 1 April 2010. |
| --- | --- |

(6)

For reasons of legal certainty, this Regulation should not apply to valid applications which are pending on 1 April 2010.

| (7) | Pursuant to Article 12 of Regulation (EC) No 297/95, the update has to be made with effect from 1 April 2010. It is therefore appropriate that this Regulation enters into force as a matter of urgency and applies from that date, |
| --- | --- |

(7)

Pursuant to Article 12 of Regulation (EC) No 297/95, the update has to be made with effect from 1 April 2010. It is therefore appropriate that this Regulation enters into force as a matter of urgency and applies from that date,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 297/95 is amended as follows:

| 1. | Article 3 is amended as follows:






  (a) | Paragraph 1 is amended as follows:






  (i) | point (a) is amended as follows:






  — | in the first subparagraph, ‘EUR 251 600’ is replaced by ‘EUR 254 100’, |
| --- | --- | --- | --- | --- |

1.

Article 3 is amended as follows:

(a)

Paragraph 1 is amended as follows:

(i)

point (a) is amended as follows:

—

in the first subparagraph, ‘EUR 251 600’ is replaced by ‘EUR 254 100’,

| — | in the second subparagraph, ‘EUR 25 200’ is replaced by ‘EUR 25 500’, |
| --- | --- |

—

in the second subparagraph, ‘EUR 25 200’ is replaced by ‘EUR 25 500’,

| — | in the third subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’, |
| --- | --- |

—

in the third subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’,

| (ii) | point (b) is amended as follows:






  — | in the first subparagraph, ‘EUR 97 600’ is replaced by ‘EUR 98 600’, |
| --- | --- | --- |

(ii)

point (b) is amended as follows:

—

in the first subparagraph, ‘EUR 97 600’ is replaced by ‘EUR 98 600’,

| — | in the second subparagraph, ‘EUR 162 600’ is replaced by ‘EUR 164 200’, |
| --- | --- |

—

in the second subparagraph, ‘EUR 162 600’ is replaced by ‘EUR 164 200’,

| — | in the third subparagraph, ‘EUR 9 700’ is replaced by ‘EUR 9 800’, |
| --- | --- |

—

in the third subparagraph, ‘EUR 9 700’ is replaced by ‘EUR 9 800’,

| — | in the fourth subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’, |
| --- | --- |

—

in the fourth subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’,

| (iii) | point (c) is amended as follows:






  — | in the first subparagraph, ‘EUR 75 500’ is replaced by ‘EUR 76 300’, |
| --- | --- | --- |

(iii)

point (c) is amended as follows:

—

in the first subparagraph, ‘EUR 75 500’ is replaced by ‘EUR 76 300’,

| — | in the second subparagraph, ‘EUR 18 900 to EUR 56 600’ is replaced by ‘EUR 19 100 to EUR 57 200’, |
| --- | --- |

—

in the second subparagraph, ‘EUR 18 900 to EUR 56 600’ is replaced by ‘EUR 19 100 to EUR 57 200’,

| — | in the third subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’, |
| --- | --- |

—

in the third subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’,

| (b) | Paragraph 2 is amended as follows:






  (i) | the first subparagraph of point (a) is amended as follows:






  — | ‘EUR 6 300’ is replaced by ‘EUR 6 400’, |
| --- | --- | --- | --- |

(b)

Paragraph 2 is amended as follows:

(i)

the first subparagraph of point (a) is amended as follows:

—

‘EUR 6 300’ is replaced by ‘EUR 6 400’,

| (ii) | point (b) is amended as follows:






  — | in the first subparagraph, ‘EUR 75 500’ is replaced by ‘EUR 76 300’, |
| --- | --- | --- |

(ii)

point (b) is amended as follows:

—

in the first subparagraph, ‘EUR 75 500’ is replaced by ‘EUR 76 300’,

| — | in the second subparagraph, ‘EUR 18 900 to EUR 56 600’ is replaced by ‘EUR 19 100 to EUR 57 200’, |
| --- | --- |

—

in the second subparagraph, ‘EUR 18 900 to EUR 56 600’ is replaced by ‘EUR 19 100 to EUR 57 200’,

| (c) | In paragraph 3, ‘EUR 12 500’ is replaced by ‘EUR 12 600’. |
| --- | --- |

(c)

In paragraph 3, ‘EUR 12 500’ is replaced by ‘EUR 12 600’.

| (d) | In paragraph 4, ‘EUR 18 900’ is replaced by ‘EUR 19 100’. |
| --- | --- |

(d)

In paragraph 4, ‘EUR 18 900’ is replaced by ‘EUR 19 100’.

| (e) | In paragraph 5, ‘EUR 6 300’ is replaced by ‘EUR 6 400’. |
| --- | --- |

(e)

In paragraph 5, ‘EUR 6 300’ is replaced by ‘EUR 6 400’.

| (f) | Paragraph 6 is amended as follows:






  (i) | in the first subparagraph, ‘EUR 90 200’ is replaced by ‘EUR 91 100’; |
| --- | --- | --- |

(f)

Paragraph 6 is amended as follows:

(i)

in the first subparagraph, ‘EUR 90 200’ is replaced by ‘EUR 91 100’;

| (ii) | in the second subparagraph, ‘EUR 22 500 to EUR 67 600’ is replaced by ‘EUR 22 700 to EUR 68 300’. |
| --- | --- |

(ii)

in the second subparagraph, ‘EUR 22 500 to EUR 67 600’ is replaced by ‘EUR 22 700 to EUR 68 300’.

| 2. | In Article 4, ‘EUR 62 800’ is replaced by ‘EUR 63 400’. |
| --- | --- |

2.

In Article 4, ‘EUR 62 800’ is replaced by ‘EUR 63 400’.

| 3. | Article 5 is amended as follows:






  (a) | Paragraph 1 is amended as follows:






  (i) | point (a) is amended as follows:






  — | in the first subparagraph, ‘EUR 125 800’ is replaced by ‘EUR 127 100’, |
| --- | --- | --- | --- | --- |

3.

Article 5 is amended as follows:

(a)

Paragraph 1 is amended as follows:

(i)

point (a) is amended as follows:

—

in the first subparagraph, ‘EUR 125 800’ is replaced by ‘EUR 127 100’,

| — | in the second subparagraph, ‘EUR 12 500’ is replaced by ‘EUR 12 600’, |
| --- | --- |

—

in the second subparagraph, ‘EUR 12 500’ is replaced by ‘EUR 12 600’,

| — | in the third subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’, |
| --- | --- |

—

in the third subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’,

| — | the fourth subparagraph is amended as follows:






  — | ‘EUR 62 800’ is replaced by ‘EUR 63 400’, |
| --- | --- | --- |

—

the fourth subparagraph is amended as follows:

—

‘EUR 62 800’ is replaced by ‘EUR 63 400’,

| — | ‘EUR 6 300’ is replaced by ‘EUR 6 400’, |
| --- | --- |

—

‘EUR 6 300’ is replaced by ‘EUR 6 400’,

| (ii) | point (b) is amended as follows:






  — | in the first subparagraph, ‘EUR 62 800’ is replaced by ‘EUR 63 400’, |
| --- | --- | --- |

(ii)

point (b) is amended as follows:

—

in the first subparagraph, ‘EUR 62 800’ is replaced by ‘EUR 63 400’,

| — | in the second subparagraph, ‘EUR 106 300’ is replaced by ‘EUR 107 400’, |
| --- | --- |

—

in the second subparagraph, ‘EUR 106 300’ is replaced by ‘EUR 107 400’,

| — | in the third subparagraph, ‘EUR 12 500’ is replaced by ‘EUR 12 600’, |
| --- | --- |

—

in the third subparagraph, ‘EUR 12 500’ is replaced by ‘EUR 12 600’,

| — | in the fourth subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’, |
| --- | --- |

—

in the fourth subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’,

| — | the fifth subparagraph is amended as follows:






  — | ‘EUR 31 400’ is replaced by ‘EUR 31 700’, |
| --- | --- | --- |

—

the fifth subparagraph is amended as follows:

—

‘EUR 31 400’ is replaced by ‘EUR 31 700’,

| — | ‘EUR 6 300’ is replaced by ‘EUR 6 400’, |
| --- | --- |

—

‘EUR 6 300’ is replaced by ‘EUR 6 400’,

| (iii) | point (c) is amended as follows:






  — | in the first subparagraph, ‘EUR 31 400’ is replaced by ‘EUR 31 700’, |
| --- | --- | --- |

(iii)

point (c) is amended as follows:

—

in the first subparagraph, ‘EUR 31 400’ is replaced by ‘EUR 31 700’,

| — | in the second subparagraph, ‘EUR 7 800 to EUR 23 500’ is replaced by ‘EUR 7 900 to EUR 23 700’, |
| --- | --- |

—

in the second subparagraph, ‘EUR 7 800 to EUR 23 500’ is replaced by ‘EUR 7 900 to EUR 23 700’,

| — | in the third subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’, |
| --- | --- |

—

in the third subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’,

| (b) | Paragraph 2 is amended as follows:






  (i) | in point (a), ‘EUR 6 300’ is replaced by ‘EUR 6 400’; |
| --- | --- | --- |

(b)

Paragraph 2 is amended as follows:

(i)

in point (a), ‘EUR 6 300’ is replaced by ‘EUR 6 400’;

| (ii) | point (b) is amended as follows:






  — | in the first subparagraph, ‘EUR 37 700’ is replaced by ‘EUR 38 100’, |
| --- | --- | --- |

(ii)

point (b) is amended as follows:

—

in the first subparagraph, ‘EUR 37 700’ is replaced by ‘EUR 38 100’,

| — | in the second subparagraph, ‘EUR 9 400 to EUR 28 300’ is replaced by ‘EUR 9 500 to EUR 28 600’, |
| --- | --- |

—

in the second subparagraph, ‘EUR 9 400 to EUR 28 300’ is replaced by ‘EUR 9 500 to EUR 28 600’,

| — | in the third subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’, |
| --- | --- |

—

in the third subparagraph, ‘EUR 6 300’ is replaced by ‘EUR 6 400’,

| (c) | In paragraph 3, ‘EUR 6 300’ is replaced by ‘EUR 6 400’. |
| --- | --- |

(c)

In paragraph 3, ‘EUR 6 300’ is replaced by ‘EUR 6 400’.

| (d) | In paragraph 4, ‘EUR 18 900’ is replaced by ‘EUR 19 100’. |
| --- | --- |

(d)

In paragraph 4, ‘EUR 18 900’ is replaced by ‘EUR 19 100’.

| (e) | In paragraph 5, ‘EUR 6 300’ is replaced by ‘EUR 6 400’. |
| --- | --- |

(e)

In paragraph 5, ‘EUR 6 300’ is replaced by ‘EUR 6 400’.

| (f) | Paragraph 6 is amended as follows:






  (i) | in the first subparagraph, ‘EUR 30 100’ is replaced by ‘EUR 30 400’; |
| --- | --- | --- |

(f)

Paragraph 6 is amended as follows:

(i)

in the first subparagraph, ‘EUR 30 100’ is replaced by ‘EUR 30 400’;

| (ii) | in the second subparagraph, ‘EUR 7 500 to EUR 22 500’ is replaced by ‘EUR 7 600 to EUR 22 700’. |
| --- | --- |

(ii)

in the second subparagraph, ‘EUR 7 500 to EUR 22 500’ is replaced by ‘EUR 7 600 to EUR 22 700’.

| 4. | In Article 6, ‘EUR 37 700’ is replaced by ‘EUR 38 100’. |
| --- | --- |

4.

In Article 6, ‘EUR 37 700’ is replaced by ‘EUR 38 100’.

| 5. | Article 7 is amended as follows:






  (a) | in the first paragraph, ‘EUR 62 800’ is replaced by ‘EUR 63 400’; |
| --- | --- | --- |

5.

Article 7 is amended as follows:

(a)

in the first paragraph, ‘EUR 62 800’ is replaced by ‘EUR 63 400’;

| (b) | in the second paragraph, ‘EUR 18 900’ is replaced by ‘EUR 19 100’. |
| --- | --- |

(b)

in the second paragraph, ‘EUR 18 900’ is replaced by ‘EUR 19 100’.

| 6. | Article 8 is amended as follows:






  (a) | Paragraph 1 is amended as follows:






  (i) | in the second subparagraph, ‘EUR 75 500’ is replaced by ‘EUR 76 300’; |
| --- | --- | --- | --- |

6.

Article 8 is amended as follows:

(a)

Paragraph 1 is amended as follows:

(i)

in the second subparagraph, ‘EUR 75 500’ is replaced by ‘EUR 76 300’;

| (ii) | in the third subparagraph, ‘EUR 37 700’ is replaced by ‘EUR 38 100’; |
| --- | --- |

(ii)

in the third subparagraph, ‘EUR 37 700’ is replaced by ‘EUR 38 100’;

| (iii) | in the fourth subparagraph, ‘EUR 18 900 to EUR 56 600’ is replaced by ‘EUR 19 100 to EUR 57 200’; |
| --- | --- |

(iii)

in the fourth subparagraph, ‘EUR 18 900 to EUR 56 600’ is replaced by ‘EUR 19 100 to EUR 57 200’;

| (iv) | in the fifth subparagraph, ‘EUR 9 400 to EUR 28 300’ is replaced by ‘EUR 9 500 to EUR 28 600’. |
| --- | --- |

(iv)

in the fifth subparagraph, ‘EUR 9 400 to EUR 28 300’ is replaced by ‘EUR 9 500 to EUR 28 600’.

| (b) | Paragraph 2 is amended as follows:






  (i) | in the second subparagraph, ‘EUR 251 600’ is replaced by ‘EUR 254 100’; |
| --- | --- | --- |

(b)

Paragraph 2 is amended as follows:

(i)

in the second subparagraph, ‘EUR 251 600’ is replaced by ‘EUR 254 100’;

| (ii) | in the third subparagraph, ‘EUR 125 800’ is replaced by ‘EUR 127 100’; |
| --- | --- |

(ii)

in the third subparagraph, ‘EUR 125 800’ is replaced by ‘EUR 127 100’;

| (iii) | in the fifth subparagraph, ‘EUR 2 700 to EUR 216 800’ is replaced by ‘EUR 2 700 to EUR 219 000’; |
| --- | --- |

(iii)

in the fifth subparagraph, ‘EUR 2 700 to EUR 216 800’ is replaced by ‘EUR 2 700 to EUR 219 000’;

| (iv) | in the sixth subparagraph, ‘EUR 108 500’ is replaced by ‘EUR 109 600’. |
| --- | --- |

(iv)

in the sixth subparagraph, ‘EUR 108 500’ is replaced by ‘EUR 109 600’.

| (c) | In paragraph 3, ‘EUR 6 300’ is replaced by ‘EUR 6 400’. |
| --- | --- |

(c)

In paragraph 3, ‘EUR 6 300’ is replaced by ‘EUR 6 400’.

Article 2

This Regulation shall not apply to valid applications pending on 1 April 2010.

Article 3

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

It shall apply from 1 April 2010.

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

Done at Brussels, 25 March 2010.

For the Commission

The President

José Manuel BARROSO

---

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

1

(2)  OJ L 136, 30.4.2004, p. 1.

2

---

| 26.3.2010 | EN | Official Journal of the European Union | L 80/40 |
| --- | --- | --- | --- |

26.3.2010

EN

Official Journal of the European Union

L 80/40

---

COMMISSION REGULATION (EU) No 262/2010

of 24 March 2010

amending for the 122nd time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with Usama bin Laden, the Al-Qaida network and the Taliban

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with Usama bin Laden, the Al-Qaida network and the Taliban, and repealing Council Regulation (EC) No 467/2001 prohibiting the export of certain goods and services to Afghanistan, strengthening the flight ban and extending the freeze of funds and other financial resources in respect of the Taliban of Afghanistan, (1) and in particular Article 7(1)(a) and 7a(1) (2) thereof,

Whereas:

| (1) | Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation. |
| --- | --- |

(1)

Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation.

| (2) | On 10 March 2010 the Sanctions Committee of the United Nations Security Council decided to remove one natural person and two legal persons or entities from its list of persons, groups and entities to whom the freezing of funds and economic resources should apply (the list). On 11 March 2010, it decided to add two natural persons to the list and to amend identifying data concerning six natural persons and one legal person or entity on the list. |
| --- | --- |

(2)

On 10 March 2010 the Sanctions Committee of the United Nations Security Council decided to remove one natural person and two legal persons or entities from its list of persons, groups and entities to whom the freezing of funds and economic resources should apply (the list). On 11 March 2010, it decided to add two natural persons to the list and to amend identifying data concerning six natural persons and one legal person or entity on the list.

| (3) | Annex I to Regulation (EC) No 881/2002 should therefore be updated accordingly, |
| --- | --- |

(3)

Annex I to Regulation (EC) No 881/2002 should therefore be updated accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EC) No 881/2002 is hereby amended as set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day following that 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 March 2010.

For the Commission, On behalf of the President,

João VALE DE ALMEIDA

Director-General for External Relations

---

(1)  OJ L 139, 29.5.2002, p. 9.

1

(2)  Article 7a was inserted by Regulation (EU) No 1286/2009 (OJ L 346, 23.12.2009, p. 42).

2

---

ANNEX

Annex I to Regulation (EC) No 881/2002 is amended as follows:

| 1. | The following entries under the heading ‘Legal persons, groups and entities’ are deleted:






  (a) | Waldenberg AG (alias (a) Al Taqwa Trade, Property and Industry; (b) Al Taqwa Trade, Property and Industry Company Limited; (c) Al Taqwa Trade, Property and Industry Establishment; (d) Himmat Establishment). Address: (a) Asat Trust Reg., Altenbach 8, FL-9490 Vaduz, Liechtenstein; (b) Via Posero, 2, 22060 Campione d'Italia, Italy. Other information: In liquidation. |
| --- | --- | --- |

1.

The following entries under the heading ‘Legal persons, groups and entities’ are deleted:

(a)

Waldenberg AG (alias (a) Al Taqwa Trade, Property and Industry; (b) Al Taqwa Trade, Property and Industry Company Limited; (c) Al Taqwa Trade, Property and Industry Establishment; (d) Himmat Establishment). Address: (a) Asat Trust Reg., Altenbach 8, FL-9490 Vaduz, Liechtenstein; (b) Via Posero, 2, 22060 Campione d'Italia, Italy. Other information: In liquidation.

| (b) | Youssef M. Nada, Via Riasc 4, CH-6911 Campione d'Italia I, Italy. |
| --- | --- |

(b)

Youssef M. Nada, Via Riasc 4, CH-6911 Campione d'Italia I, Italy.

| (c) | Youssef M. Nada & Co. Gesellschaft m.b.H. Address: Kaertner Ring 2/2/5/22, A-1010 Vienna, Austria. Other information: Company dissolved in October 2002, deleted from Company Registry as of November 2002. |
| --- | --- |

(c)

Youssef M. Nada & Co. Gesellschaft m.b.H. Address: Kaertner Ring 2/2/5/22, A-1010 Vienna, Austria. Other information: Company dissolved in October 2002, deleted from Company Registry as of November 2002.

| 2. | The following entries shall be added under the heading ‘Natural persons’:






  (a) | Akram Turki Hishan Al-Mazidih (alias (a) Akram Turki Al-Hishan, (b) Abu Jarrah, (c) Abu Akram). Date of birth: (a) 1974, (b) 1975 (c) 1979. Address: Zabadani, Syrian Arab Republic. Date of designation referred to in Article 2a (4) (b): 11.3.2010. |
| --- | --- | --- |

2.

The following entries shall be added under the heading ‘Natural persons’:

(a)

Akram Turki Hishan Al-Mazidih (alias (a) Akram Turki Al-Hishan, (b) Abu Jarrah, (c) Abu Akram). Date of birth: (a) 1974, (b) 1975 (c) 1979. Address: Zabadani, Syrian Arab Republic. Date of designation referred to in Article 2a (4) (b): 11.3.2010.

| (b) | Ghazy Fezza Hishan Al-Mazidih (alias (a) Ghazy Fezzaa Hishan, (b) Mushari Abd Aziz Saleh Shlash, (c) Abu Faysal, (d) Abu Ghazzy). Date of birth: (a) 1974, (b) 1975. Address: Zabadani, Syrian Arab Republic. Date of designation referred to in Article 2a (4) (b): 11.3.2010. |
| --- | --- |

(b)

Ghazy Fezza Hishan Al-Mazidih (alias (a) Ghazy Fezzaa Hishan, (b) Mushari Abd Aziz Saleh Shlash, (c) Abu Faysal, (d) Abu Ghazzy). Date of birth: (a) 1974, (b) 1975. Address: Zabadani, Syrian Arab Republic. Date of designation referred to in Article 2a (4) (b): 11.3.2010.

| 3. | The entry ‘Global Relief Foundation (GRF) (alias (a) Fondation Secours Mondial (FSM), (b) Secours mondial de France (SEMONDE), (c) Fondation Secours Mondial — Belgique a.s.b.l., (d) Fondation Secours Mondial v.z.w, (e) FSM, (f) Stichting Wereldhulp — België, v.z.w., (g) Fondation Secours Mondial — Kosova, (h) Fondation Secours Mondial “World Relief”). Address: (a) 9935 South 76th Avenue, Unit 1, Bridgeview, Illinois 60455, U.S.A.; (b) PO Box 1406, Bridgeview, Illinois 60455, U.S.A.; (c) 49 rue du Lazaret, 67100 Strasbourg, France; (d) Vaatjesstraat 29, 2580 Putte, Belgium; (e) Rue des Bataves 69, 1040 Etterbeek (Brussels), Belgium; (f) PO Box 6, 1040 Etterbeek 2 (Brussels), Belgium; (g) Mula Mustafe Baseskije Street 72, Sarajevo, Bosnia and Herzegovina; (h) Put Mladih Muslimana Street 30/A, Sarajevo, Bosnia and Herzegovina; (i) 64 Potur Mahala Street, Travnik, Bosnia and Herzegovina; (j) Rr. Skenderbeu 76, Lagjja Sefa, Gjakova, Kosovo; (k) Ylli Morina Road, Djakovica, Kosovo; (l) Rruga e Kavajes, Building No 3, Apartment No 61, PO Box 2892, Tirana, Albania; (m) House 267 Street No 54, Sector F — 11/4, Islamabad, Pakistan. Other information: (a) Other foreign locations: Afghanistan, Azerbaijan, Bangladesh, Chechnya (Russia), China, Eritrea, Ethiopia, Georgia, India, Ingushetia (Russia), Iraq, Jordan, Lebanon, West Bank and Gaza, Sierra Leone, Somalia and Syria; (b) U.S. Federal Employer Identification: 36-3804626; (c) V.A.T. Number: BE 454419759; (d) Belgian addresses are those of Fondation Secours Mondial — Belgique a.s.b.l and Fondation Secours Mondial vzw. and Stichting Wereldhulp — België, v.z.w since 1998. Date of designation referred to in Article 2a (4) (b): 22.10.2002.’ under the heading ‘Legal persons, groups and entities’ shall be replaced by the following:
  Global Relief Foundation (GRF) (alias (a) Fondation Secours Mondial (FSM), (b) Secours mondial de France (SEMONDE), (c) Fondation Secours Mondial — Belgique a.s.b.l., (d) Fondation Secours Mondial v.z.w, (e) FSM, (f) Stichting Wereldhulp — België, v.z.w., (g) Fondation Secours Mondial — Kosova, h) Fondation Secours Mondial ‘World Relief’. Address: (a) 9935 South 76th Avenue, Unit 1, Bridgeview, Illinois 60455, U.S.A.; (b) PO Box 1406, Bridgeview, Illinois 60455, U.S.A.; (c) 49 rue du Lazaret, 67100 Strasbourg, France; (d) Vaatjesstraat 29, 2580 Putte, Belgium; (e) Rue des Bataves 69, 1040 Etterbeek (Brussels), Belgium; (f) PO Box 6, 1040 Etterbeek 2 (Brussels), Belgium; (g) Mula Mustafe Baseskije Street 72, Sarajevo, Bosnia and Herzegovina; (h) Put Mladih Muslimana Street 30/A, Sarajevo, Bosnia and Herzegovina; (i) 64 Potur Mahala Street, Travnik, Bosnia and Herzegovina; (j) Rr. Skenderbeu 76, Lagjja Sefa, Gjakova, Kosovo; (k) Ylli Morina Road, Djakovica, Kosovo; (l) Rruga e Kavajes, Building No. 3, Apartment No 61, PO Box 2892, Tirana, Albania; (m) House 267 Street No 54, Sector F — 11/4, Islamabad, Pakistan. Other information: (a) Other foreign locations: Afghanistan, Azerbaijan, Bangladesh, China, Eritrea, Ethiopia, Georgia, India, Iraq, Jordan, Lebanon, West Bank and Gaza, Sierra Leone, Somalia and Syria; (b) U.S. Federal Employer Identification: 36-3804626; (c) V.A.T. Number: BE 454419759; (d) Belgian addresses are those of Fondation Secours Mondial — Belgique a.s.b.l and Fondation Secours Mondial vzw. and Stichting Wereldhulp — België, v.z.w since 1998. Date of designation referred to in Article 2a (4) (b): 22.10.2002. |
| --- | --- |

3.

The entry ‘Global Relief Foundation (GRF) (alias (a) Fondation Secours Mondial (FSM), (b) Secours mondial de France (SEMONDE), (c) Fondation Secours Mondial — Belgique a.s.b.l., (d) Fondation Secours Mondial v.z.w, (e) FSM, (f) Stichting Wereldhulp — België, v.z.w., (g) Fondation Secours Mondial — Kosova, (h) Fondation Secours Mondial “World Relief”). Address: (a) 9935 South 76th Avenue, Unit 1, Bridgeview, Illinois 60455, U.S.A.; (b) PO Box 1406, Bridgeview, Illinois 60455, U.S.A.; (c) 49 rue du Lazaret, 67100 Strasbourg, France; (d) Vaatjesstraat 29, 2580 Putte, Belgium; (e) Rue des Bataves 69, 1040 Etterbeek (Brussels), Belgium; (f) PO Box 6, 1040 Etterbeek 2 (Brussels), Belgium; (g) Mula Mustafe Baseskije Street 72, Sarajevo, Bosnia and Herzegovina; (h) Put Mladih Muslimana Street 30/A, Sarajevo, Bosnia and Herzegovina; (i) 64 Potur Mahala Street, Travnik, Bosnia and Herzegovina; (j) Rr. Skenderbeu 76, Lagjja Sefa, Gjakova, Kosovo; (k) Ylli Morina Road, Djakovica, Kosovo; (l) Rruga e Kavajes, Building No 3, Apartment No 61, PO Box 2892, Tirana, Albania; (m) House 267 Street No 54, Sector F — 11/4, Islamabad, Pakistan. Other information: (a) Other foreign locations: Afghanistan, Azerbaijan, Bangladesh, Chechnya (Russia), China, Eritrea, Ethiopia, Georgia, India, Ingushetia (Russia), Iraq, Jordan, Lebanon, West Bank and Gaza, Sierra Leone, Somalia and Syria; (b) U.S. Federal Employer Identification: 36-3804626; (c) V.A.T. Number: BE 454419759; (d) Belgian addresses are those of Fondation Secours Mondial — Belgique a.s.b.l and Fondation Secours Mondial vzw. and Stichting Wereldhulp — België, v.z.w since 1998. Date of designation referred to in Article 2a (4) (b): 22.10.2002.’ under the heading ‘Legal persons, groups and entities’ shall be replaced by the following:

Global Relief Foundation (GRF) (alias (a) Fondation Secours Mondial (FSM), (b) Secours mondial de France (SEMONDE), (c) Fondation Secours Mondial — Belgique a.s.b.l., (d) Fondation Secours Mondial v.z.w, (e) FSM, (f) Stichting Wereldhulp — België, v.z.w., (g) Fondation Secours Mondial — Kosova, h) Fondation Secours Mondial ‘World Relief’. Address: (a) 9935 South 76th Avenue, Unit 1, Bridgeview, Illinois 60455, U.S.A.; (b) PO Box 1406, Bridgeview, Illinois 60455, U.S.A.; (c) 49 rue du Lazaret, 67100 Strasbourg, France; (d) Vaatjesstraat 29, 2580 Putte, Belgium; (e) Rue des Bataves 69, 1040 Etterbeek (Brussels), Belgium; (f) PO Box 6, 1040 Etterbeek 2 (Brussels), Belgium; (g) Mula Mustafe Baseskije Street 72, Sarajevo, Bosnia and Herzegovina; (h) Put Mladih Muslimana Street 30/A, Sarajevo, Bosnia and Herzegovina; (i) 64 Potur Mahala Street, Travnik, Bosnia and Herzegovina; (j) Rr. Skenderbeu 76, Lagjja Sefa, Gjakova, Kosovo; (k) Ylli Morina Road, Djakovica, Kosovo; (l) Rruga e Kavajes, Building No. 3, Apartment No 61, PO Box 2892, Tirana, Albania; (m) House 267 Street No 54, Sector F — 11/4, Islamabad, Pakistan. Other information: (a) Other foreign locations: Afghanistan, Azerbaijan, Bangladesh, China, Eritrea, Ethiopia, Georgia, India, Iraq, Jordan, Lebanon, West Bank and Gaza, Sierra Leone, Somalia and Syria; (b) U.S. Federal Employer Identification: 36-3804626; (c) V.A.T. Number: BE 454419759; (d) Belgian addresses are those of Fondation Secours Mondial — Belgique a.s.b.l and Fondation Secours Mondial vzw. and Stichting Wereldhulp — België, v.z.w since 1998. Date of designation referred to in Article 2a (4) (b): 22.10.2002.

| 4. | The entry ‘Mohamed Abu Dhess (alias (a) Yaser Hassan, born 1.2.1966, (b) Abu Ali Abu Mohamed Dhees, born 1.2.1966 in Hasmija, (c) Mohamed Abu Dhess, born 1.2.1966 in Hashmija, Iraq). Date of birth: (a) 22.2.1964, (b) 1.2.1966. Place of birth: Irbid, Jordan. Nationality: Jordanian. Passport No: (a) German International travel document No 0695982, expired; (b) German International travel document No 0785146, valid until 8.4.2004. Other information: (a) Name of father: Mouhemad Saleh Hassan; (b) Name of mother: Mariam Hassan, née Chalabia; (c) In prison in Germany as at October 2008. Date of designation referred to in Article 2a (4) (b): 23.9.2003.’ under the heading ‘Natural persons’ shall be replaced by the following:
  Mohamed Ghassan Ali Abu Dhess (alias (a) Yaser Hassan, born 1.2.1966, (b) Abu Ali Abu Mohamed Dhees, born 1.2.1966 in Hasmija, (c) Mohamed Abu Dhess, born 1.2.1966 in Hashmija, Iraq). Date of birth: (a) 22.6.1966, (b) 1.2.1966. Place of birth: Irbid, Jordan. Nationality: Jordanian. Passport No: (a) German International travel document No 0695982, expired; (b) German International travel document No 0785146, valid until 8.4.2004. Other information: (a) Name of father: Mouhemad Saleh Hassan; (b) Name of mother: Mariam Hassan, née Chalabia; (c) In prison in Germany as at October 2008. Date of designation referred to in Article 2a (4) (b): 23.9.2003. |
| --- | --- |

4.

The entry ‘Mohamed Abu Dhess (alias (a) Yaser Hassan, born 1.2.1966, (b) Abu Ali Abu Mohamed Dhees, born 1.2.1966 in Hasmija, (c) Mohamed Abu Dhess, born 1.2.1966 in Hashmija, Iraq). Date of birth: (a) 22.2.1964, (b) 1.2.1966. Place of birth: Irbid, Jordan. Nationality: Jordanian. Passport No: (a) German International travel document No 0695982, expired; (b) German International travel document No 0785146, valid until 8.4.2004. Other information: (a) Name of father: Mouhemad Saleh Hassan; (b) Name of mother: Mariam Hassan, née Chalabia; (c) In prison in Germany as at October 2008. Date of designation referred to in Article 2a (4) (b): 23.9.2003.’ under the heading ‘Natural persons’ shall be replaced by the following:

Mohamed Ghassan Ali Abu Dhess (alias (a) Yaser Hassan, born 1.2.1966, (b) Abu Ali Abu Mohamed Dhees, born 1.2.1966 in Hasmija, (c) Mohamed Abu Dhess, born 1.2.1966 in Hashmija, Iraq). Date of birth: (a) 22.6.1966, (b) 1.2.1966. Place of birth: Irbid, Jordan. Nationality: Jordanian. Passport No: (a) German International travel document No 0695982, expired; (b) German International travel document No 0785146, valid until 8.4.2004. Other information: (a) Name of father: Mouhemad Saleh Hassan; (b) Name of mother: Mariam Hassan, née Chalabia; (c) In prison in Germany as at October 2008. Date of designation referred to in Article 2a (4) (b): 23.9.2003.

| 5. | The entry ‘Ismail Mohamed Ismail Abu Shaweesh. Date of birth: 10.3.1977. Place of birth: Benghazi, Libya. Nationality: Stateless Palestinian. Passport No: (a) 0003684 (Egyptian travel document), (b) 981354 (Egyptian passport). Other information: In remand detention at Weiterstadt Prison, Germany since 22 May 2005’ under the heading ‘Natural persons’ shall be replaced by the following:
  Ismail Mohamed Ismail Abu Shaweesh. Date of birth: 10.3.1977. Place of birth: Benghazi, Libya. Nationality: Stateless Palestinian. Passport No: (a) 0003684 (Egyptian travel document), (b) 981354 (Egyptian passport). Other information: In detention in Germany since 22.5.2005. Date of designation referred to in Article 2a (4) (b): 2.8.2006. |
| --- | --- |

5.

The entry ‘Ismail Mohamed Ismail Abu Shaweesh. Date of birth: 10.3.1977. Place of birth: Benghazi, Libya. Nationality: Stateless Palestinian. Passport No: (a) 0003684 (Egyptian travel document), (b) 981354 (Egyptian passport). Other information: In remand detention at Weiterstadt Prison, Germany since 22 May 2005’ under the heading ‘Natural persons’ shall be replaced by the following:

Ismail Mohamed Ismail Abu Shaweesh. Date of birth: 10.3.1977. Place of birth: Benghazi, Libya. Nationality: Stateless Palestinian. Passport No: (a) 0003684 (Egyptian travel document), (b) 981354 (Egyptian passport). Other information: In detention in Germany since 22.5.2005. Date of designation referred to in Article 2a (4) (b): 2.8.2006.

| 6. | The entry ‘Yasser Mohamed Ismail Abu Shaweesh (alias Yasser Mohamed Abou Shaweesh). Date of birth: 20.11.1973. Place of birth: Benghazi, Libya. Passport No: (a) 939254 (Egyptian travel document), (b) 0003213 (Egyptian passport), (c) 981358 (Egyptian passport), (d) “C00071659” (passport substitute issued by the Federal Republic of Germany). Other information: in detention in Wuppertal, Germany as of January 2005’ under the heading ‘Natural persons’ shall be replaced by the following:
  Yasser Mohamed Ismail Abu Shaweesh (alias Yasser Mohamed Abou Shaweesh). Date of birth: 20.11.1973. Place of birth: Benghazi, Libya. Passport No: (a) 939254 (Egyptian travel document), (b) 0003213 (Egyptian passport), (c) 981358 (Egyptian passport), (d) C00071659 (passport substitute issued by the Federal Republic of Germany). Other information: In detention in Germany as of January 2005. Date of designation referred to in Article 2a (4) (b): 6.12.2005. |
| --- | --- |

6.

The entry ‘Yasser Mohamed Ismail Abu Shaweesh (alias Yasser Mohamed Abou Shaweesh). Date of birth: 20.11.1973. Place of birth: Benghazi, Libya. Passport No: (a) 939254 (Egyptian travel document), (b) 0003213 (Egyptian passport), (c) 981358 (Egyptian passport), (d) “C00071659” (passport substitute issued by the Federal Republic of Germany). Other information: in detention in Wuppertal, Germany as of January 2005’ under the heading ‘Natural persons’ shall be replaced by the following:

Yasser Mohamed Ismail Abu Shaweesh (alias Yasser Mohamed Abou Shaweesh). Date of birth: 20.11.1973. Place of birth: Benghazi, Libya. Passport No: (a) 939254 (Egyptian travel document), (b) 0003213 (Egyptian passport), (c) 981358 (Egyptian passport), (d) C00071659 (passport substitute issued by the Federal Republic of Germany). Other information: In detention in Germany as of January 2005. Date of designation referred to in Article 2a (4) (b): 6.12.2005.

| 7. | The entry ‘Aschraf Al-Dagma (alias Aschraf Al Dagma). Date of birth: 28.4.1969. Place of birth: (a) Absan, Gaza Strip, Palestinian Territories, (b) Kannyouiz, Palestinian Teritorries. Nationality: Unresolved/Palestinian origin Passport No: Refugee travel document issued by Landratsamt Altenburger Land (Altenburg County Administration Office), Germany, dated 30 April 2000. Other information: In prison in Germany as at October 2008. Date of designation referred to in Article 2a (4) (b): 23.9.2003’ under the heading ‘Natural persons’ shall be replaced by the following:
  Aschraf Al-Dagma (alias Aschraf Al Dagma). Date of birth: 28.4.1969. Place of birth: (a) Absan, Gaza Strip, Palestinian Territories, (b) Kannyouiz, Palestinian Teritorries. Nationality: Unresolved/Palestinian origin. Passport No: Refugee travel document issued by Landratsamt Altenburger Land (Altenburg County Administration Office), Germany, dated 30.4. 2000. Other information: In Germany as at February 2010. Date of designation referred to in Article 2a (4) (b): 23.9.2003. |
| --- | --- |

7.

The entry ‘Aschraf Al-Dagma (alias Aschraf Al Dagma). Date of birth: 28.4.1969. Place of birth: (a) Absan, Gaza Strip, Palestinian Territories, (b) Kannyouiz, Palestinian Teritorries. Nationality: Unresolved/Palestinian origin Passport No: Refugee travel document issued by Landratsamt Altenburger Land (Altenburg County Administration Office), Germany, dated 30 April 2000. Other information: In prison in Germany as at October 2008. Date of designation referred to in Article 2a (4) (b): 23.9.2003’ under the heading ‘Natural persons’ shall be replaced by the following:

Aschraf Al-Dagma (alias Aschraf Al Dagma). Date of birth: 28.4.1969. Place of birth: (a) Absan, Gaza Strip, Palestinian Territories, (b) Kannyouiz, Palestinian Teritorries. Nationality: Unresolved/Palestinian origin. Passport No: Refugee travel document issued by Landratsamt Altenburger Land (Altenburg County Administration Office), Germany, dated 30.4. 2000. Other information: In Germany as at February 2010. Date of designation referred to in Article 2a (4) (b): 23.9.2003.

| 8. | The entry ‘Shamil Salmanovich Basayev (Басаев Шамиль Салманович) (alias (a) Abdullakh Shamil Abu-Idris, (b) Shamil Basaev, (c) Basaev Chamil, (d) Basaev Shamil Shikhanovic, (e) Terek, (f) Lysy, (g) Idris, (h) Besznogy, (i) Amir, (j) Rasul, (k) Spartak, (l) Pantera-05, (m) Hamzat, (n) General, (o) Baisangur I, (p) Walid, (q)Al-Aqra, (r) Rizvan, (s) Berkut, (t) Assadula). Date of birth: 14.1.1965. Place of birth: (a) Dyshni-Vedeno, Vedensk district, Chechen-Ingush Autonomous Soviet Socialist Republic Russian Federation, (b) Vedenskiey District, Chechnya Republic, Russian Federation. Nationality: Russian. Passport No: 623334 (Russian passport, January 2002). National identification No: IY-OZH No 623334 (issued on 9.6.1989 by the Vedensk district). Date of designation referred to in Article 2a (4) (b): 12.8.2003’ under the heading ‘Natural persons’ shall be replaced by the following:
  Shamil Salmanovich Basayev (Басаев Шамиль Салманович) (alias (a) Abdullakh Shamil Abu-Idris, (b) Shamil Basaev, (c) Basaev Chamil, (d) Basaev Shamil Shikhanovic, (e) Terek, (f) Lysy, (g) Idris, (h) Besznogy, (i) Amir, (j) Rasul, (k) Spartak, (l) Pantera-05, (m) Hamzat, (n) General, (o) Baisangur I, (p) Walid, (q)Al-Aqra, (r) Rizvan, (s) Berkut, (t) Assadula). Date of birth: 14.1.1965. Place of birth: (a) Dyshni-Vedeno, Vedensk district, Chechen-Ingush Autonomous Soviet Socialist Republic Russian Federation, (b) Vedenskiey District, Chechnya Republic, Russian Federation. Nationality: Russian. Passport No: 623334 (Russian passport, January 2002). National identification No: IY-OZH No 623334 (issued on 9.6.1989 by the Vedensk district). Other information: Confirmed to have died as of 2006. Date of designation referred to in Article 2a (4) (b): 12.8.2003. |
| --- | --- |

8.

The entry ‘Shamil Salmanovich Basayev (Басаев Шамиль Салманович) (alias (a) Abdullakh Shamil Abu-Idris, (b) Shamil Basaev, (c) Basaev Chamil, (d) Basaev Shamil Shikhanovic, (e) Terek, (f) Lysy, (g) Idris, (h) Besznogy, (i) Amir, (j) Rasul, (k) Spartak, (l) Pantera-05, (m) Hamzat, (n) General, (o) Baisangur I, (p) Walid, (q)Al-Aqra, (r) Rizvan, (s) Berkut, (t) Assadula). Date of birth: 14.1.1965. Place of birth: (a) Dyshni-Vedeno, Vedensk district, Chechen-Ingush Autonomous Soviet Socialist Republic Russian Federation, (b) Vedenskiey District, Chechnya Republic, Russian Federation. Nationality: Russian. Passport No: 623334 (Russian passport, January 2002). National identification No: IY-OZH No 623334 (issued on 9.6.1989 by the Vedensk district). Date of designation referred to in Article 2a (4) (b): 12.8.2003’ under the heading ‘Natural persons’ shall be replaced by the following:

Shamil Salmanovich Basayev (Басаев Шамиль Салманович) (alias (a) Abdullakh Shamil Abu-Idris, (b) Shamil Basaev, (c) Basaev Chamil, (d) Basaev Shamil Shikhanovic, (e) Terek, (f) Lysy, (g) Idris, (h) Besznogy, (i) Amir, (j) Rasul, (k) Spartak, (l) Pantera-05, (m) Hamzat, (n) General, (o) Baisangur I, (p) Walid, (q)Al-Aqra, (r) Rizvan, (s) Berkut, (t) Assadula). Date of birth: 14.1.1965. Place of birth: (a) Dyshni-Vedeno, Vedensk district, Chechen-Ingush Autonomous Soviet Socialist Republic Russian Federation, (b) Vedenskiey District, Chechnya Republic, Russian Federation. Nationality: Russian. Passport No: 623334 (Russian passport, January 2002). National identification No: IY-OZH No 623334 (issued on 9.6.1989 by the Vedensk district). Other information: Confirmed to have died as of 2006. Date of designation referred to in Article 2a (4) (b): 12.8.2003.

| 9. | The entry ‘Dawood Ibrahim Kaskar (alias (a) Dawood Ebrahim, (b) Sheikh Dawood Hassan, (c) Abdul Hamid Abdul Aziz, (d) Anis Ibrahim, (e) Aziz Dilip, (f) Daud Hasan Shaikh Ibrahim Kaskar, (g) Daud Ibrahim Memon Kaskar, (h) Dawood Hasan Ibrahim Kaskar, (i) Dawood Ibrahim Memon, (j) Dawood Sabri, (k) Kaskar Dawood Hasan, (l) Shaikh Mohd Ismail Abdul Rehman, (m) Dowood Hassan Shaikh Ibrahim, (n) Ibrahim Shaikh Mohd Anis, (o) Shaikh Ismail Abdul, (p) Hizrat). Title: (a) Sheikh, (b) Shaikh. Address: (a) White House, Near Saudi Mosque, Clifton, Karachi, Pakistan, (b) House Nu 37 — 30th Street — defence, Housing Authority, Karachi Pakistan. Date of birth: 26.12.1955. Place of birth: (a) Bombay, (b) Ratnagiri, India. Nationality: Indian. Passport No: (a) A-333602 (Indian passport issued on 4.6.1985 in Bombay, India), (b) M110522 (Indian passport issued on 13.11.1978 in Bombay, India), (c) R841697 (Indian passport issued on 26.11.1981 in Bombay), (d) F823692 (JEDDAH) (Indian passport issued by CGI in Jeddah, on 2.9.1989), (e) A501801 (BOMBAY) (Indian passport issued on 26.7.1985), (f) K560098 (BOMBAY) (Indian passport issued on 30.7.1975), (g) V57865 (BOMBAY) (issued on 3.10.1983), (h) P537849 (BOMBAY) (issued on 30.7.1979), (i) A717288 (MISUSE) (issued on 18.8.1985 in Dubai, (j) G866537 (MISUSE) (Pakistani passport issued on 12.8.1991 in Rawalpindi). Other information: (a) passport No A-333602 has been revoked by the Government of India, (b) international arrest warrant issued by the Government of India’ under the heading ‘Natural persons’ shall be replaced by the following:
  Dawood Ibrahim Kaskar (alias (a) Dawood Ebrahim, (b) Sheikh Dawood Hassan, (c) Abdul Hamid Abdul Aziz, (d) Anis Ibrahim, (e) Aziz Dilip, (f) Daud Hasan Shaikh Ibrahim Kaskar, (g) Daud Ibrahim Memon Kaskar, (h) Dawood Hasan Ibrahim Kaskar, (i) Dawood Ibrahim Memon, (j) Dawood Sabri, (k) Kaskar Dawood Hasan, (l) Shaikh Mohd Ismail Abdul Rehman, (m) Dowood Hassan Shaikh Ibrahim, (n) Ibrahim Shaikh Mohd Anis, (o) Shaikh Ismail Abdul, (p) Hizrat). Title: (a) Sheikh, (b) Shaikh. Address: (a) White House, Near Saudi Mosque, Clifton, Karachi, Pakistan, (b) House Nu 37 — 30th Street — defence, Housing Authority, Karachi Pakistan. Date of birth: 26.12.1955. Place of birth: (a) Bombay, (b) Ratnagiri, India. Nationality: Indian. Passport No: (a) A-333602 (Indian passport issued on 4.6.1985 in Bombay, India), (b) M110522 (Indian passport issued on 13.11.1978 in Bombay, India), (c) R841697 (Indian passport issued on 26.11.1981 in Bombay), (d) F823692 (JEDDAH) (Indian passport issued by CGI in Jeddah, on 2.9.1989), (e) A501801 (BOMBAY) (Indian passport issued on 26.7.1985), (f) K560098 (BOMBAY) (Indian passport issued on 30.7.1975), (g) V57865 (BOMBAY) (issued on 3.10.1983), (h) P537849 (BOMBAY) (issued on 30.7.1979), (i) A717288 (MISUSE) (issued on 18.8.1985 in Dubai, (j) G866537 (MISUSE) (Pakistani passport issued on 12.8.1991 in Rawalpindi), (k) C-267185 (issued in Karachi in July 1996), (l) H-123259 (issued in Rawalpindi in July 2001), (m) G-869537 (issued in Rawalpindi), (n) KC-285901. Other information: Passport No A-333602 has been revoked by the Government of India. Date of designation referred to in Article 2a (4) (b): 3.11.2003. |
| --- | --- |

9.

The entry ‘Dawood Ibrahim Kaskar (alias (a) Dawood Ebrahim, (b) Sheikh Dawood Hassan, (c) Abdul Hamid Abdul Aziz, (d) Anis Ibrahim, (e) Aziz Dilip, (f) Daud Hasan Shaikh Ibrahim Kaskar, (g) Daud Ibrahim Memon Kaskar, (h) Dawood Hasan Ibrahim Kaskar, (i) Dawood Ibrahim Memon, (j) Dawood Sabri, (k) Kaskar Dawood Hasan, (l) Shaikh Mohd Ismail Abdul Rehman, (m) Dowood Hassan Shaikh Ibrahim, (n) Ibrahim Shaikh Mohd Anis, (o) Shaikh Ismail Abdul, (p) Hizrat). Title: (a) Sheikh, (b) Shaikh. Address: (a) White House, Near Saudi Mosque, Clifton, Karachi, Pakistan, (b) House Nu 37 — 30th Street — defence, Housing Authority, Karachi Pakistan. Date of birth: 26.12.1955. Place of birth: (a) Bombay, (b) Ratnagiri, India. Nationality: Indian. Passport No: (a) A-333602 (Indian passport issued on 4.6.1985 in Bombay, India), (b) M110522 (Indian passport issued on 13.11.1978 in Bombay, India), (c) R841697 (Indian passport issued on 26.11.1981 in Bombay), (d) F823692 (JEDDAH) (Indian passport issued by CGI in Jeddah, on 2.9.1989), (e) A501801 (BOMBAY) (Indian passport issued on 26.7.1985), (f) K560098 (BOMBAY) (Indian passport issued on 30.7.1975), (g) V57865 (BOMBAY) (issued on 3.10.1983), (h) P537849 (BOMBAY) (issued on 30.7.1979), (i) A717288 (MISUSE) (issued on 18.8.1985 in Dubai, (j) G866537 (MISUSE) (Pakistani passport issued on 12.8.1991 in Rawalpindi). Other information: (a) passport No A-333602 has been revoked by the Government of India, (b) international arrest warrant issued by the Government of India’ under the heading ‘Natural persons’ shall be replaced by the following:

Dawood Ibrahim Kaskar (alias (a) Dawood Ebrahim, (b) Sheikh Dawood Hassan, (c) Abdul Hamid Abdul Aziz, (d) Anis Ibrahim, (e) Aziz Dilip, (f) Daud Hasan Shaikh Ibrahim Kaskar, (g) Daud Ibrahim Memon Kaskar, (h) Dawood Hasan Ibrahim Kaskar, (i) Dawood Ibrahim Memon, (j) Dawood Sabri, (k) Kaskar Dawood Hasan, (l) Shaikh Mohd Ismail Abdul Rehman, (m) Dowood Hassan Shaikh Ibrahim, (n) Ibrahim Shaikh Mohd Anis, (o) Shaikh Ismail Abdul, (p) Hizrat). Title: (a) Sheikh, (b) Shaikh. Address: (a) White House, Near Saudi Mosque, Clifton, Karachi, Pakistan, (b) House Nu 37 — 30th Street — defence, Housing Authority, Karachi Pakistan. Date of birth: 26.12.1955. Place of birth: (a) Bombay, (b) Ratnagiri, India. Nationality: Indian. Passport No: (a) A-333602 (Indian passport issued on 4.6.1985 in Bombay, India), (b) M110522 (Indian passport issued on 13.11.1978 in Bombay, India), (c) R841697 (Indian passport issued on 26.11.1981 in Bombay), (d) F823692 (JEDDAH) (Indian passport issued by CGI in Jeddah, on 2.9.1989), (e) A501801 (BOMBAY) (Indian passport issued on 26.7.1985), (f) K560098 (BOMBAY) (Indian passport issued on 30.7.1975), (g) V57865 (BOMBAY) (issued on 3.10.1983), (h) P537849 (BOMBAY) (issued on 30.7.1979), (i) A717288 (MISUSE) (issued on 18.8.1985 in Dubai, (j) G866537 (MISUSE) (Pakistani passport issued on 12.8.1991 in Rawalpindi), (k) C-267185 (issued in Karachi in July 1996), (l) H-123259 (issued in Rawalpindi in July 2001), (m) G-869537 (issued in Rawalpindi), (n) KC-285901. Other information: Passport No A-333602 has been revoked by the Government of India. Date of designation referred to in Article 2a (4) (b): 3.11.2003.

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| 26.3.2010 | EN | Official Journal of the European Union | L 80/44 |
| --- | --- | --- | --- |

26.3.2010

EN

Official Journal of the European Union

L 80/44

---

COMMISSION REGULATION (EU) No 263/2010

of 25 March 2010

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

THE EUROPEAN COMMISSION,

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

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

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

Whereas:

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

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

This Regulation shall enter into force on 26 March 2010.

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

Done at Brussels, 25 March 2010.

For the Commission, On behalf of the President,

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

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

1

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

2

---

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 | IL | 126,5 |
| JO | 64,0 |
| MA | 114,8 |
| TN | 135,9 |
| TR | 89,8 |
| ZZ | 106,2 |
| 0707 00 05 | JO | 75,8 |
| MA | 75,4 |
| TR | 135,4 |
| ZZ | 95,5 |
| 0709 90 70 | MA | 143,0 |
| TR | 106,8 |
| ZZ | 124,9 |
| 0805 10 20 | EG | 42,9 |
| IL | 52,4 |
| MA | 51,1 |
| TN | 47,9 |
| TR | 63,7 |
| ZZ | 51,6 |
| 0805 50 10 | EG | 66,4 |
| IL | 91,6 |
| MA | 49,1 |
| TR | 66,5 |
| ZA | 69,5 |
| ZZ | 68,6 |
| 0808 10 80 | AR | 87,7 |
| BR | 88,2 |
| CA | 100,2 |
| CL | 86,9 |
| CN | 72,9 |
| MK | 24,7 |
| US | 131,5 |
| UY | 68,2 |
| ZA | 82,0 |
| ZZ | 82,5 |
| 0808 20 50 | AR | 87,1 |
| CL | 74,0 |
| CN | 35,0 |
| US | 134,2 |
| UY | 106,8 |
| ZA | 98,3 |
| ZZ | 89,2 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

IL

126,5

JO

64,0

MA

114,8

TN

135,9

TR

89,8

ZZ

106,2

0707 00 05

JO

75,8

MA

75,4

TR

135,4

ZZ

95,5

0709 90 70

MA

143,0

TR

106,8

ZZ

124,9

0805 10 20

EG

42,9

IL

52,4

MA

51,1

TN

47,9

TR

63,7

ZZ

51,6

0805 50 10

EG

66,4

IL

91,6

MA

49,1

TR

66,5

ZA

69,5

ZZ

68,6

0808 10 80

AR

87,7

BR

88,2

CA

100,2

CL

86,9

CN

72,9

MK

24,7

US

131,5

UY

68,2

ZA

82,0

ZZ

82,5

0808 20 50

AR

87,1

CL

74,0

CN

35,0

US

134,2

UY

106,8

ZA

98,3

ZZ

89,2

---

(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’.

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| 26.3.2010 | EN | Official Journal of the European Union | L 80/46 |
| --- | --- | --- | --- |

26.3.2010

EN

Official Journal of the European Union

L 80/46

---

COMMISSION REGULATION (EU) No 264/2010

of 25 March 2010

amending the representative prices and additional import duties for certain products in the sugar sector fixed by Regulation (EC) No 877/2009 for the 2009/10 marketing year

THE EUROPEAN COMMISSION,

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

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

Having regard to Commission Regulation (EC) No 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 2009/10 marketing year are fixed by Commission Regulation (EC) No 877/2009 (3). These prices and duties have been last amended by Commission Regulation (EU) No 253/2010 (4). |
| --- | --- |

(1)

The representative prices and additional duties applicable to imports of white sugar, raw sugar and certain syrups for the 2009/10 marketing year are fixed by Commission Regulation (EC) No 877/2009 (3). These prices and duties have been last amended by Commission Regulation (EU) No 253/2010 (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 877/2009 for the 2009/10, marketing year, are hereby amended as set out in the Annex hereto.

Article 2

This Regulation shall enter into force on 26 March 2010.

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

Done at Brussels, 25 March 2010.

For the Commission, On behalf of the President,

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development

---

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

1

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

2

(3)  OJ L 253, 25.9.2009, p. 3.

3

(4)  OJ L 79, 25.3.2010, p. 11.

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 26 March 2010

| (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) | 35,27 | 0,70 |
| 1701 11 90 (1) | 35,27 | 4,32 |
| 1701 12 10 (1) | 35,27 | 0,57 |
| 1701 12 90 (1) | 35,27 | 4,03 |
| 1701 91 00 (2) | 36,48 | 6,99 |
| 1701 99 10 (2) | 36,48 | 3,39 |
| 1701 99 90 (2) | 36,48 | 3,39 |
| 1702 90 95 (3) | 0,36 | 0,31 |

(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)

35,27

0,70

1701 11 90 (1)

35,27

4,32

1701 12 10 (1)

35,27

0,57

1701 12 90 (1)

35,27

4,03

1701 91 00 (2)

36,48

6,99

1701 99 10 (2)

36,48

3,39

1701 99 90 (2)

36,48

3,39

1702 90 95 (3)

0,36

0,31

---

(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.

---

DECISIONS

| 26.3.2010 | EN | Official Journal of the European Union | L 80/48 |
| --- | --- | --- | --- |

26.3.2010

EN

Official Journal of the European Union

L 80/48

---

COUNCIL DECISION 2010/179/CFSP

of 11 March 2010

in support of SEESAC arms control activities in the Western Balkans, in the framework of the EU Strategy to combat the illicit accumulation and trafficking of SALW and their ammunition

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 26(2) thereof,

Whereas:

| (1) | The excessive and uncontrolled accumulation and spread of small arms and light weapons (SALW) has fuelled insecurity in south-eastern Europe, exacerbating conflict in the region and undermining post-conflict peace building, thus posing a serious threat to peace and security in the region. |
| --- | --- |

(1)

The excessive and uncontrolled accumulation and spread of small arms and light weapons (SALW) has fuelled insecurity in south-eastern Europe, exacerbating conflict in the region and undermining post-conflict peace building, thus posing a serious threat to peace and security in the region.

| (2) | On 15-16 December 2005, the European Council adopted the EU Strategy to combat the illicit accumulation and trafficking of SALW and their ammunition (EU SALW Strategy) which sets the guidelines for EU action in the field of SALW. |
| --- | --- |

(2)

On 15-16 December 2005, the European Council adopted the EU Strategy to combat the illicit accumulation and trafficking of SALW and their ammunition (EU SALW Strategy) which sets the guidelines for EU action in the field of SALW.

| (3) | The EU SALW Strategy identifies among its objectives the fostering of effective multilateralism so as to forge mechanisms, whether international, regional or within the EU and its Member States, for countering the supply and destabilising the spread of SALW and their ammunition. The EU SALW Strategy also identifies the Western Balkans as one of the regions most affected by the illicit trade and excessive accumulation of weapons. |
| --- | --- |

(3)

The EU SALW Strategy identifies among its objectives the fostering of effective multilateralism so as to forge mechanisms, whether international, regional or within the EU and its Member States, for countering the supply and destabilising the spread of SALW and their ammunition. The EU SALW Strategy also identifies the Western Balkans as one of the regions most affected by the illicit trade and excessive accumulation of weapons.

| (4) | Under the auspices of the United Nations Development Programme (UNDP) and the former Stability Pact for South-Eastern Europe (since 2008 known as Regional Cooperation Council), a ‘South-Eastern and Eastern Europe Clearinghouse for the Control of Small Arms and Light Weapons’ (SEESAC) has been established. SEESAC is located in Belgrade, and consists of a technical support unit, which supports a number of regional and national level operational activities. |
| --- | --- |

(4)

Under the auspices of the United Nations Development Programme (UNDP) and the former Stability Pact for South-Eastern Europe (since 2008 known as Regional Cooperation Council), a ‘South-Eastern and Eastern Europe Clearinghouse for the Control of Small Arms and Light Weapons’ (SEESAC) has been established. SEESAC is located in Belgrade, and consists of a technical support unit, which supports a number of regional and national level operational activities.

| (5) | The objectives pursued by SEESAC include preventing the proliferation and excessive accumulation of SALW and their ammunition throughout south-east Europe. SEESAC places particular emphasis on the development of regional projects to address the reality of cross-border flows of weapons. |
| --- | --- |

(5)

The objectives pursued by SEESAC include preventing the proliferation and excessive accumulation of SALW and their ammunition throughout south-east Europe. SEESAC places particular emphasis on the development of regional projects to address the reality of cross-border flows of weapons.

| (6) | The EU previously supported SEESAC by Council Decision 2002/842/CFSP of 21 October 2002, implementing Joint Action 2002/589/CFSP, extended and amended by Council Decisions 2003/807/CFSP of 17 November 2003 and 2004/791/CFSP of 22 November 2004. The implementation of these Decisions has been positively assessed by the Council, |
| --- | --- |

(6)

The EU previously supported SEESAC by Council Decision 2002/842/CFSP of 21 October 2002, implementing Joint Action 2002/589/CFSP, extended and amended by Council Decisions 2003/807/CFSP of 17 November 2003 and 2004/791/CFSP of 22 November 2004. The implementation of these Decisions has been positively assessed by the Council,

HAS ADOPTED THIS DECISION:

Article 1

1.   The EU shall pursue the promotion of peace and security in the Western Balkans by supporting effective multilateralism and for relevant regional initiatives aiming at reducing the risk posed to peace and security by the proliferation and excessive accumulation of SALW and their ammunition.

2.   In order to achieve the objective referred to in paragraph 1, the EU will support a SEESAC project which aims to reduce the threat posed by SALW to security in the Western Balkans. The activities to be supported by the EU shall have the following specific objectives:

| — | to improve the management and security of unsafe and unstable stockpiles of weapons and ammunition, |
| --- | --- |

—

to improve the management and security of unsafe and unstable stockpiles of weapons and ammunition,

| — | to reduce the available stockpiles of weapons and ammunition through destruction activities, |
| --- | --- |

—

to reduce the available stockpiles of weapons and ammunition through destruction activities,

| — | to enhance controls on SALW, including through the implementation of international and national instruments on marking and tracing in the Western Balkans countries and improvement of the weapons registration process.
  A detailed description of the project is set out in the Annex. |
| --- | --- |

—

to enhance controls on SALW, including through the implementation of international and national instruments on marking and tracing in the Western Balkans countries and improvement of the weapons registration process.

A detailed description of the project is set out in the Annex.

Article 2

1.   The High Representative of the Union for Foreign Affairs and Security Policy (HR), shall be responsible for the implementation of this Decision.

2.   The technical implementation of the project referred to in Article 1(2) shall be carried out by SEESAC. It shall perform its task under the responsibility of the HR. For this purpose, the HR shall enter into the necessary arrangements with SEESAC.

Article 3

1.   The financial reference amount for the implementation of the project referred to in Article 1(2) shall be EUR 1 600 000.

2.   The expenditure financed by the amount set out in paragraph 1 shall be managed in accordance with the procedures and rules applicable to the general budget of the European Union.

3.   The Commission shall supervise the proper management of the expenditure referred to in paragraph 1. For this purpose, it shall conclude a financing agreement with UNDP, acting on behalf of SEESAC. The agreement shall stipulate that SEESAC is to ensure the visibility of the EU contribution, appropriate to its size.

4.   The Commission shall endeavour to conclude the financing agreement referred to in paragraph 3 as soon as possible after the entry into force of this Decision. It shall inform the Council of any difficulties in that process and of the date of conclusion of the financing agreement.

Article 4

The HR shall report to the Council on the implementation of this Decision on the basis of regular reports prepared by SEESAC. These reports shall form the basis for the evaluation carried out by the Council. The Commission shall report on the financial aspects of the implementation of the project.

Article 5

1.   This Decision shall enter into force on the day of its adoption.

2.   This Decision shall expire 24 months after the date of conclusion of the financing agreement referred to in Article 3(3), or six months after the date of its adoption if no financing agreement has been concluded within that period.

Article 6

This Decision shall be published in the Official Journal of the European Union.

Done at Brussels, 11 March 2010.

For the Council

The President

J. BLANCO

---

ANNEX

EU CONTRIBUTION TO SEESAC PROJECT ON SALW IN THE WESTERN BALKANS

1.   Introduction

The large-scale accumulation of small arms and light weapons (SALW) in south-east Europe has been recognised as an important challenge to peace and security by the EU SALW Strategy. The countries in the Western Balkans have been of a particular concern due to the historical accumulation of weapons and munitions stockpiles. Not only does this region remain directly affected by the proliferation of SALW and their ammunition, but it also continues to present risks of trafficking of weapons to conflict areas elsewhere.

Currently the main challenge for the Western Balkan countries is the practical implementation of their legal and political commitments in the area of SALW control, including the UN Programme of Action on SALW and the International Marking and Tracing Instrument (ITI).

Consequently, in order to minimise the risk of proliferation of SALW, it is crucial to increase safety of existing stockpiles of SALW and ammunitions, to destroy surpluses and to establish more stringent controls on SALW, including through the implementation at regional level of the ITI and improvement of the registration process. These objectives and activities are in line with those laid down in the EU SALW Strategy. SEESAC proposes to conduct projects relating to these three areas of activities.

2.   Project description

2.1.   Improved stockpile management

2.1.1.   Regional training modules on SALW stockpile management

In order to assist in increasing the safety and security of stockpiles of weapons and ammunition, the project envisages the development of three learning modules for officials responsible for material resources in the Ministries of Defence and the Ministries of Interior of countries in the Western Balkans. The course will be offered to the inspection teams and officers in order to help familiarise them with best practices in stockpile management techniques.

The implementation of the project will result in increased awareness of international standards and best practices in stockpile management. The level and quality of implementation stockpile management procedures will be enhanced, thus increasing the safety and security of stockpiles.

2.1.2.   Improved safety and security at SALW and ammunition storage sites

The project will improve the safety and security of weapons and ammunition storage sites in the Western Balkans by providing specific technical and infrastructure assistance in order to enhance safe storage capacities. The project activities will assist the Ministries of Defence in Bosnia and Herzegovina and Montenegro as well as the Ministry of the Interior of Croatia in procuring and installing the necessary equipment for securing weapons and ammunition stockpiles. Training will be provided for staff in charge of stockpile management.

The project will result in increased security provisions and access control at the selected sites, thus improving the safety of ammunition stocks. As a consequence the risk of theft and of uncontrolled explosions will be significantly reduced through better control of the state of the ammunition and weapons.

2.2.   SALW destruction

The objective of the project is to increase security and diminish the risk of proliferation by significantly reducing the number of surplus weapons in storage. In order to reduce the surplus SALW held by the Ministries of Interior in Croatia and Serbia, the project will conduct several SALW destruction activities. In Croatia, the project envisages the destruction of some 30 000 weapons. In Serbia, the number of weapons to be destroyed is estimated at 40 000.

The project will result in a significantly reduced number of surplus and confiscated SALW in the Ministry of Interior storages in Croatia and Serbia. The destruction of recovered weapons will significantly contribute to preventing further proliferation of SALW. In addition, this will lead to improved security as well as increased awareness of SALW issues in these two countries.

2.3.   Increased controls on SALW

2.3.1.   Development of national weapons registration and record-keeping systems

The project will provide for the development or upgrade of the existing systems for weapons registration, licensing and record-keeping. The registration systems will include operations related to keeping track of firearms owned by an individual and/or legal entity and the amount of ammunition it is authorised to possess. The support for record-keeping will include development of software product/s that identify not only the weapons in civilian possession but also operations related to the management of weapons, ammunition and/or explosives in depots, approved warehouses or armouries, such as a local police station or central storage site. It will thus be possible to identify weapons, the users and the storage location of equipment, when not in use. The project activities will also provide for adequate technical infrastructure for the implementation of the weapons registration software.

The development and establishment of electronic system(s) for weapons registration and record-keeping will result in the implementation of the requirements for registration and record-keeping established under the UN Firearms Protocol and the ITI.

2.3.2.   Collection and registration of weapons

The project aims at supporting the collection of any weapon, explosive device, ordnance and associated ammunition, including through the legalisation of weapons in civilian possession through their registration.

The awareness-raising actions will be coordinated by committees consisting of specialists of the Ministries of Interior and UNDP/SEESAC, joined by relevant other PR experts where necessary, in order to properly disseminate details about the legalisation and voluntary surrender of illegal firearms. The campaigns will focus on local dissemination channels that are able to reach the local level most effectively. Local information dissemination will be reinforced at the national level through reporting, interviews, and documentaries. Information on the campaigns will be provided through electronic and written media. The campaign messages will be positive and show law implementation in practice.

The project will enhance security across the Western Balkans by taking dangerous weapons off the streets through a two-way communication between the public and the police. In particular, the project will reach all age-groups in possession of illegal weapons and all those who intend to acquire weapons.

2.3.3.   Regional seminar on marking and tracing

The project provides for the organisation of a two-day regional seminar provisionally envisaged to be held in Belgrade, Serbia. The seminar will provide an update on adherence to international instruments and the adoption of national legislation on marking and tracing in the Western Balkans. The seminar will provide for a review of the implementation of the national legislation. A specific objective will be the implementation of the requirement for marking of imported weapons under the UN Firearms Protocol.

Participants in this regional seminar will include, inter alia, representatives from the Western Balkan’s countries, international organisations and NGOs, national industries and technical experts from EU Member States. It is expected that up to 50 participants will attend this seminar.

The seminar will produce a report of the presentations and discussions and of the recommendations. The seminar documents will be made available online.

3.   Duration

The total estimated duration of the project will be 24 months.

4.   Beneficiaries

The beneficiaries of the project are the national institutions in Western Balkan countries responsible for arms control and stockpile management.

The general population of the countries within the Western Balkans will benefit from the project due to the reduced risk of insecurity and instability from the widespread proliferation of SALW.

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| 26.3.2010 | EN | Official Journal of the European Union | L 80/52 |
| --- | --- | --- | --- |

26.3.2010

EN

Official Journal of the European Union

L 80/52

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COMMISSION DECISION

of 25 March 2010

on amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products

(notified under document C(2010) 1867)

(Text with EEA relevance)

(2010/180/EU)

THE EUROPEAN COMMISSION,

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

Having regard 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 (1), and in particular Article 16f thereof,

Having regard to the opinion of the European Medicines Agency, formulated on 6 November 2008 by the Committee for Herbal Medicinal Products,

Whereas:

| (1) | Mentha x piperita L. can be considered as a herbal substance, a herbal preparation or a combination thereof within the meaning of Directive 2001/83/EC and complies with the requirements set out in that Directive. |
| --- | --- |

(1)

Mentha x piperita L. can be considered as a herbal substance, a herbal preparation or a combination thereof within the meaning of Directive 2001/83/EC and complies with the requirements set out in that Directive.

| (2) | It is therefore appropriate to include Mentha x piperita L. in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/EC (2). |
| --- | --- |

(2)

It is therefore appropriate to include Mentha x piperita L. in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/EC (2).

| (3) | In order to avoid duplications and possible contradictions between the Annexes and Articles 1 and 2 of Decision 2008/911/EC, it is appropriate to remove the references to single substances in those Articles. |
| --- | --- |

(3)

In order to avoid duplications and possible contradictions between the Annexes and Articles 1 and 2 of Decision 2008/911/EC, it is appropriate to remove the references to single substances in those Articles.

| (4) | Decision 2008/911/EC should therefore be amended accordingly. |
| --- | --- |

(4)

Decision 2008/911/EC should therefore be amended accordingly.

| (5) | The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use, |
| --- | --- |

(5)

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

HAS ADOPTED THIS DECISION:

Article 1

Decision 2008/911/EC is amended as follows:

| 1. | Articles 1 and 2 are replaced by the following:
  ‘Article 1
  A list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products is established in Annex I.
  Article 2
  The indications, the specified strengths and the posology, the route of administration and any other information necessary for the safe use of the herbal substance as a traditional medicinal product relevant for the herbal substances listed in Annex I are set out in Annex II.’. |
| --- | --- |

1.

Articles 1 and 2 are replaced by the following:

‘Article 1

A list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products is established in Annex I.

Article 2

The indications, the specified strengths and the posology, the route of administration and any other information necessary for the safe use of the herbal substance as a traditional medicinal product relevant for the herbal substances listed in Annex I are set out in Annex II.’.

| 2. | Annexes I and II are amended in accordance with the Annex to this Decision. |
| --- | --- |

2.

Annexes I and II are amended in accordance with the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 25 March 2010.

For the Commission

John DALLI

Member of the Commission

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

1

(2)  OJ L 328, 6.12.2008, p. 42.

2

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ANNEX

Annexes I and II to Decision 2008/911/EC are amended as follows:

| 1. | in Annex I, the following substance is inserted after Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung (sweet fennel fruit):
  ‘Mentha x piperita L.’; |
| --- | --- |

1.

in Annex I, the following substance is inserted after Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung (sweet fennel fruit):

‘Mentha x piperita L.’;

| 2. | in Annex II, the following is inserted after the entry relating to Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung, fructus:
  ‘COMMUNITY LIST ENTRY ON MENTHA x PIPERITA L., AETHEROLEUM


  Scientific name of the plant


  Mentha x piperita L.

  Botanical family

  Lamiaceae (Labiatae)

  Herbal preparation(s)

  Peppermint oil: essential oil obtained by steam distillation from the fresh aerial parts of the flowering plant

  European Pharmacopoeia monograph reference

  Peppermint oil — Menthae piperitae aetheroleum (01/2008:0405)

  Indication(s)

  Herbal medicinal product traditionally used:






  1. | for the relief of symptoms in coughs and colds; |
| --- | --- | --- |

2.

in Annex II, the following is inserted after the entry relating to Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung, fructus:

‘COMMUNITY LIST ENTRY ON MENTHA x PIPERITA L., AETHEROLEUM

Scientific name of the plant

Mentha x piperita L.

Botanical family

Lamiaceae (Labiatae)

Herbal preparation(s)

Peppermint oil: essential oil obtained by steam distillation from the fresh aerial parts of the flowering plant

European Pharmacopoeia monograph reference

Peppermint oil — Menthae piperitae aetheroleum (01/2008:0405)

Indication(s)

Herbal medicinal product traditionally used:

1.

for the relief of symptoms in coughs and colds;

| 2. | for the symptomatic relief of localised muscle pain; |
| --- | --- |

2.

for the symptomatic relief of localised muscle pain;

| 3. | for the symptomatic relief of localised pruritic conditions in intact skin. |
| --- | --- |

3.

for the symptomatic relief of localised pruritic conditions in intact skin.

The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

Type of tradition

European

Specified strength

Indications 1, 2 and 3

Single dose

Children between 4 to 10 years of age

Semi-solid preparations 2-10 %

Hydroethanolic preparations 2-4 %

Children between 10 to 12 years of age, adolescents between 12 to 16 years of age

Semi-solid preparations 5-15 %

Hydroethanolic preparations 3-6 %

Adolescents over 16 years of age, adults

Semi-solid and oily preparations 5-20 %

In aqueous-ethanol preparations 5-10 %

In nasal ointments 1-5 % essential oil.

Specified posology

Up to three times daily

The use in children under 2 years of age is contraindicated (see “Contraindications”).

The use is not recommended in children between 2 to 4 years of age (see “Special warnings and precautions for use”).

Route of administration

Cutaneous and transdermal.

Duration of use or any restrictions on the duration of use

Indication 1

Not to be used for more than 2 weeks.

Indications 2 and 3

It is not recommended to use the medicinal product continuously for more than 3 months.

If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Any other information necessary for the safe use

Contraindications

Children under 2 years of age, because menthol can induce reflex apnoea and laryngospasm.

Children with history of seizures (febrile or not).

Hypersensitivity to peppermint oil or menthol.

Special warnings and precautions for use

Eye contact with unwashed hands after the application of peppermint oil may potentially cause irritation.

Peppermint oil should not be applied on broken or irritated skin.

The use is not recommended in children between 2 to 4 years of age, as there is no sufficient experience available.

Interactions with other medicinal products and other forms of interaction

None reported.

Pregnancy and lactation

In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

Undesirable effects

Hypersensitivity reactions such as skin rash, contact dermatitis, and eye irritation have been reported. These reactions are most of the time mild and transient. The frequency is not known.

Irritation of the skin and mucosa of the nose is possible, after local application. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.

Overdose

No case of overdose has been reported.’

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