ISSN 1725-2555

Official Journal

of the European Union

L 352

European flag  

English edition

Legislation

Volume 51
31 December 2008


Contents

 

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

page

 

 

REGULATIONS

 

*

Council Regulation (EC) No 1359/2008 of 28 November 2008 fixing for 2009 and 2010 the fishing opportunities for Community fishing vessels for certain deep-sea fish stocks

1

 

*

Council Regulation (EC) No 1360/2008 of 2 December 2008 amending Regulation (EC) No 332/2002 establishing a facility providing medium-term financial assistance for Member States’ balances of payments

11

 

*

Council Regulation (EC) No 1361/2008 of 16 December 2008 amending Regulation (EC) No 219/2007 on the establishment of a joint undertaking to develop the new generation European air traffic management system (SESAR)

12

 

*

Council Regulation (EC) No 1362/2008 of 18 December 2008 amending Regulation (EC) No 2505/96 opening and providing for the administration of autonomous Community tariff quotas for certain agricultural and industrial products

18

 

 

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

 

 

DECISIONS

 

 

Council

 

 

2008/979/EC

 

*

Council Decision of 18 December 2008 on the signing on behalf of the Community and the provisional application of the Agreement between the European Community and the Swiss Confederation amending Annex 11 to the Agreement between the European Community and the Swiss Confederation on trade in agricultural products

23

Agreement between the European Community and the Swiss Confederation amending Annex 11 to the Agreement between the European Community and the Swiss Confederation on trade in agricultural products

24

 

 

Commission

 

 

2008/980/EC

 

*

Commission Decision of 5 December 2008 appointing members and alternates of the Committee for Advanced Therapies to represent clinicians and patients associations ( 1 )

31

 

 

2008/981/EC

 

*

Commission Decision of 5 December 2008 extending the derogations from certain provisions of Council Directive 91/440/EEC and Directive 2001/14/EC of the European Parliament and of the Council granted to Ireland and the United Kingdom in respect of Northern Ireland (notified under document number C(2008) 7703)

32

 

 

2008/982/EC

 

*

Commission Decision of 8 December 2008 authorising the United Kingdom to conclude an agreement with the Bailiwick of Jersey, the Bailiwick of Guernsey and the Isle of Man for transfers of funds between the United Kingdom and each of these territories to be treated as transfers of funds within the United Kingdom, pursuant to Regulation (EC) No 1781/2006 of the European Parliament and of the Council (notified under document number C(2008) 7812)

34

 

 

2008/983/EC

 

*

Commission Decision of 9 December 2008 authorising the United Kingdom to benefit from a provision laid down in point 8.5 of Annex IIA to Council Regulation (EC) No 40/2008 as regards a fishing effort pool system for trawlers and similar fishing vessels operating in the North Sea and to the west of Scotland (notified under document number C(2008) 7801)

36

 

 

2008/984/EC

 

*

Commission Decision of 10 December 2008 amending Annex C to Council Directive 64/432/EEC and Decision 2004/226/EC as regards diagnostic tests for bovine brucellosis (notified under document number C(2008) 7642)  ( 1 )

38

 

 

2008/985/EC

 

*

Commission Decision of 15 December 2008 authorising the placing on the market of leaves of Morinda citrifolia as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (notified under document number C(2008) 8108)

46

 

 

2008/986/EC

 

*

Commission Decision of 15 December 2008 concerning the non-inclusion of antraquinone in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance (notified under document number C(2008) 8133)  ( 1 )

48

 

 

2008/987/EC

 

*

Commission Decision of 16 December 2008 on the allocation to Latvia of additional fishing days in the Baltic Sea within subdivisions 25 and 26 (notified under document number C(2008) 8217)

50

 

 

2008/988/EC

 

*

Commission Decision of 17 December 2008 amending Decision 2008/185/EC as regards the inclusion of the Netherlands in the list of Member States free of Aujeszky’s disease and of Hungary in the list of Member States where an approved national control programme for that disease is in place (notified under document number C(2008) 8325)  ( 1 )

52

 

 

2008/989/EC

 

*

Commission Decision of 23 December 2008 authorising Member States, in accordance with Council Directive 1999/105/EC, to take decisions on the equivalence of the guarantees afforded by forest reproductive material to be imported from certain third countries (notified under document number C(2008) 8589)

55

 

 

European Central Bank

 

 

2008/990/EC

 

*

Decision of the European Central Bank of 11 December 2008 on the approval of the volume of coin issuance in 2009 (ECB/2008/20)

58

 

 

ACP-CE Council of Ministers

 

 

2008/991/EC

 

*

Decision No 3/2008 of the ACP-EC Council of Ministers of 15 December 2008 to adopt amendments to Annex IV to the Partnership Agreement

59

 

*

Information on the date of entry into force of the decision modifying Annex IV to the ACP-EC Partnership Agreement

61

 

*

Notice concerning the provisional application of the CARIFORUM-EC Economic Partnership Agreement

62

 

 

Corrigenda

 

*

Corrigendum to Decision 2007/792/EC of the Representatives of the Governments of the Member States meeting within the Council of 26 November 2007 amending Decision 2005/446/EC setting the deadline for the commitment of the funds of the Ninth European Development Fund (EDF) (OJ L 320, 6.12.2007)

63

 

 

 

*

Note to the reader (see page 3 of the cover)

s3

 


 

(1)   Text with EEA relevance

EN

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

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


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

REGULATIONS

31.12.2008   

EN

Official Journal of the European Union

L 352/1


COUNCIL REGULATION (EC) No 1359/2008

of 28 November 2008

fixing for 2009 and 2010 the fishing opportunities for Community fishing vessels for certain deep-sea fish stocks

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 2371/2002 of 20 December 2002 on the conservation and sustainable exploitation of fisheries resources under the common fisheries policy (1), and in particular Article 20 thereof,

Having regard to the proposal of the Commission,

Whereas:

(1)

Under Article 4 of Regulation (EC) No 2371/2002 the Council is to adopt the measures necessary to ensure access to waters and resources and the sustainable pursuit of fishing activities taking into account available scientific advice and any advice received from Regional Advisory Councils established under Article 31 of that Regulation.

(2)

Under Article 20 of Regulation (EC) No 2371/2002, it is incumbent upon the Council to establish fishing opportunities by fishery or group of fisheries and to allocate them in accordance with prescribed criteria.

(3)

The latest scientific advice from the International Council for the Exploration of the Sea (ICES) concerning certain stocks of fish found in the deep sea indicates that those stocks are harvested unsustainably, and that fishing opportunities for those stocks should be reduced in order to assure their sustainability.

(4)

The ICES has further advised that the exploitation rate of orange roughy in ICES subarea VII is much too high. Scientific advice further indicates that orange roughy in subarea VI is heavily depleted, and areas of vulnerable aggregations of that species have been identified. It is therefore appropriate to prohibit fishing for orange roughy in those areas.

(5)

In accordance with Council Regulation (EC) No 2347/2002 of 16 December 2002 establishing specific access requirements and associated conditions applicable to fishing for deep-sea stocks (2), the fishing opportunities for deep-sea species, as defined in Annex I to that Regulation, are decided on a bi-annual basis. Nevertheless, an exception is made for the stocks of greater silver smelt and blue ling for which the fishing opportunities depend on the outcome of the annual negotiations with Norway. The fishing possibilities for those stocks therefore remain to be established in the annual fishing opportunities regulation decided by the Council in December.

(6)

In order to ensure effective management of quotas, the specific conditions under which fishing operations occur should be established.

(7)

In accordance with Article 2 of Council Regulation (EC) No 847/96 of 6 May 1996 introducing additional conditions for year-to-year management of TACs and quotas (3), it is necessary to indicate which stocks are subject to the various measures fixed therein.

(8)

The measures provided for in this Regulation should be fixed by reference to ICES zones as defined in Council Regulation (EEC) No 3880/91 of 17 December 1991 on the submission of nominal catch statistics by Member States fishing in the north-east Atlantic (4) and to CECAF zones (Committee for Eastern Central Atlantic Fisheries) as defined in Council Regulation (EC) No 2597/95 of 23 October 1995 on the submission of nominal catch statistics by Member States fishing in certain areas other than those of the North Atlantic (5).

(9)

The fishing opportunities should be used in accordance with the Community legislation on the matter, and in particular with Commission Regulation (EEC) No 2807/83 of 22 September 1983 laying down detailed rules for recording information on Member States’ catches of fish (6), Commission Regulation (EEC) No 1381/87 of 20 May 1987 establishing detailed rules concerning the marking and documentation of fishing vessels (7), Council Regulation (EEC) No 2847/93 of 12 October 1993 establishing a control system applicable to the common fisheries policy (8), Council Regulation (EC) No 1627/94 of 27 June 1994 laying down general provisions concerning special fishing permits (9), Council Regulation (EC) No 850/98 of 30 March 1998 for the conservation of fishery resources through technical measures for the protection of juveniles of marine organisms (10), Regulation (EC) No 2347/2002 and Council Regulation (EC) No 2187/2005 of 21 December 2005 for the conservation of fishery resources through technical measures in the Baltic Sea, the Belts and the Sound (11).

(10)

In order to ensure the livelihood of Community fishermen, it is important to open these fisheries on 1 January 2009. Given the urgency of the matter, it is imperative to grant an exception to the six-week period referred to in point I(3) of the Protocol on the role of national parliaments in the European Union, annexed to the Treaty on European Union and to the Treaties establishing the European Communities,

HAS ADOPTED THIS REGULATION:

Article 1

Subject-matter

This Regulation fixes for the years 2009 and 2010 the annual fishing opportunities available to Community fishing vessels for stocks of deep-sea species in Community waters and in certain non-Community waters where catch limitations are required, and the specific conditions under which such fishing opportunities may be used.

Article 2

Definitions

1.   For the purposes of this Regulation, ‘deep-sea fishing permit’ means the fishing permit referred to in Article 3 of Regulation (EC) No 2347/2002.

2.   The definitions of ICES and CECAF zones are those given, respectively, in Regulation (EEC) No 3880/91 and Regulation (EC) No 2597/95.

Article 3

Fixing of fishing opportunities

Fishing opportunities for stocks of deep-sea species for Community vessels are fixed as set out in the Annex.

Article 4

Allocation among Member States

The allocation of fishing opportunities among Member States provided for in the Annex shall be without prejudice to:

(a)

exchanges made pursuant to Article 20(5) of Regulation (EC) No 2371/2002;

(b)

reallocations made pursuant to Articles 21(4) and 32(2) of Regulation (EEC) No 2847/93 and Article 23(4) of Regulation (EC) No 2371/2002;

(c)

additional landings allowed pursuant to Article 3 of Regulation (EC) No 847/96;

(d)

quantities withheld pursuant to Article 4 of Regulation (EC) No 847/96;

(e)

deductions made pursuant to Article 5 of Regulation (EC) No 847/96 and Article 23(4) of Regulation (EC) No 2371/2002.

Article 5

Quota flexibility

For the purposes of Regulation (EC) No 847/96, all quotas in the Annex to the present Regulation shall be considered ‘Analytical’ quotas.

However, the measures provided for in Article 5(2) of Regulation (EC) No 847/96 shall not apply to those quotas.

Article 6

Conditions for landing catch and by-catch

1.   Fish from stocks for which fishing opportunities are fixed by this Regulation may be retained on board or landed only if they were taken by vessels of a Member State which has a quota which is not exhausted. All landings shall count against the quota.

2.   Paragraph 1 shall not apply to catches taken in the course of scientific investigations carried out in accordance with Article 43 of Regulation (EC) No 850/98. Such catches shall not count against the quota.

Article 7

Orange roughy

1.   Fishing for orange roughy shall be prohibited in the following sea areas:

(a)

that sea area enclosed by rhumb lines sequentially joining the following positions:

 

57°00′ N, 11°00′ W

 

57°00′ N, 8°30′ W

 

56°23′ N, 8°30′ W

 

55°00′ N, 8°30′ W

 

55°00′ N, 11°00′ W

 

57°00′ N, 11°00′ W;

(b)

that sea area enclosed by rhumb lines sequentially joining the following positions:

 

55°30′ N, 15°49′ W

 

53°30′ N, 14°11′ W

 

50°30′ N, 14°11′ W

 

50°30′ N, 15°49′ W;

(c)

that sea area enclosed by rhumb lines sequentially joining the following positions:

 

55°00′ N, 13°51′ W

 

55°00′ N, 10°37′ W

 

54°15′ N, 10°37′ W

 

53°30′ N, 11°50′ W

 

53°30′ N, 13°51′ W.

Those positions and the corresponding rhumb lines and vessel positions shall be measured according to the WGS84 standard.

2.   Vessels holding a deep-sea fishing permit that have entered the areas defined in paragraph 1 shall not retain on board or tranship any quantity of orange roughy, nor land any quantity of orange roughy at the end of that fishing trip unless:

(a)

all gears carried on board are lashed and stowed during the transit in accordance with the conditions laid down in Article 20(1) of Regulation (EEC) No 2847/93; or

(b)

the average speed during transit is equal to, or greater than, 8 knots.

3.   Member States shall ensure that vessels holding a deep-sea fishing permit are properly monitored by the Fisheries Monitoring Centres (FMC), which shall have a system to detect and record the vessels’ entry into, transit through and exit from the areas defined in paragraph 1.

Article 8

Entry into force

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

It shall apply from 1 January 2009.

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

Done at Brussels, 28 November 2008.

For the Council

The President

M. BARNIER


(1)  OJ L 358, 31.12.2002, p. 59.

(2)  OJ L 351, 28.12.2002, p. 6.

(3)  OJ L 115, 9.5.1996, p. 3.

(4)  OJ L 365, 31.12.1991, p. 1.

(5)  OJ L 270, 13.11.1995, p. 1.

(6)  OJ L 276, 10.10.1983, p. 1.

(7)  OJ L 132, 21.5.1987, p. 9.

(8)  OJ L 261, 20.10.1993, p. 1.

(9)  OJ L 171, 6.7.1994, p. 7.

(10)  OJ L 125, 27.4.1998, p. 1.

(11)  OJ L 349, 31.12.2005, p. 1.


ANNEX

PART 1

Definition of Species and Species Groups

1.

In the list set out in part 2 of this Annex, fish stocks are referred to following the alphabetical order of the Latin names of the species. However, deep-sea sharks are placed at the beginning of that list. A table of correspondences of common names and Latin names is given below for the purposes of this Regulation:

Common name

Scientific name

Black scabbardfish

Aphanopus carbo

Alfonsinos

Beryx spp.

Roundnose grenadier

Coryphaenoides rupestris

Orange roughy

Hoplostethus atlanticus

Blue ling

Molva dypterygia

Red seabream

Pagellus bogaraveo

Forkbeards

Phycis blennoides

2.

For the purposes of this Regulation, ‘deep-sea sharks’, means the following list of species:

Common name

Scientific name

Iceland catshark

Apristuris spp.

Gulper shark

Centrophorus granulosus

Leafscale gulper shark

Centrophorus squamosus

Portuguese dogfish

Centroscymnus coelolepis

Longnose velvet dogfish

Centroscymnus crepidater

Black dogfish

Centroscyllium fabricii

Birdbeak dogfish

Deania calceus

Kitefin shark

Dalatias licha

Greater lanternshark

Etmopterus princeps

Velvet belly

Etmopterus spinax

Blackmouth dogfish

Galeus melastomus

Mouse catshark

Galeus murinus

Greenland shark

Somniosus microcephalus

PART 2

Annual fishing opportunities applicable for Community vessels in areas where catch limitations exist by species and by area (in tonnes live weight)

All references are to ICES subareas and/or divisions unless otherwise stated.

Species

:

Deep-sea sharks

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of V, VI, VII, VIII and IX (DWS/56789-)

Year

2009 (1)

2010 (2)

 

Germany

20

0

 

Estonia

1

0

 

Ireland

55

0

 

Spain

93

0

 

France

339

0

 

Lithuania

1

0

 

Poland

1

0

 

Portugal

127

0

 

United Kingdom

187

0

 

EC

824

0

 


Species

:

Deep-sea sharks

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of X (DWS/10-)

Year

2009 (3)

2010 (4)

 

Portugal

10

0

 

EC

10

0

 


Species

:

Deep-sea sharks and Deania histricosa and Deania profondorum

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of XII (DWS/12-)

Year

2009 (5)

2010 (6)

 

Ireland

1

0

 

Spain

17

0

 

France

6

0

 

United Kingdom

1

0

 

EC

25

0

 


Species

:

Black scabbardfish

Aphanopus carbo

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of I, II, III and IV (BSF/1234-)

Year

2009

2010

 

Germany

4

4

 

France

4

4

 

United Kingdom

4

4

 

EC

12

12

 


Species

:

Black scabbardfish

Aphanopus carbo

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of V, VI, VII and XII (BSF/56712-)

Year

2009

2010

 

Germany

32

29

 

Estonia

15

14

 

Ireland

78

73

 

Spain

156

145

 

France

2 189

2 036

 

Latvia

102

95

 

Lithuania

1

1

 

Poland

1

1

 

United Kingdom

156

145

 

Others (7)

8

8 (7)

 

EC

2 738

2 547

 


Species

:

Black scabbardfish

Aphanopus carbo

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of VIII, IX and X (BSF/8910-)

Year

2009

2010

 

Spain

11

11

 

France

28

26

 

Portugal

3 561

3 311

 

EC

3 600

3 348

 


Species

:

Black scabbardfish

Aphanopus carbo

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of CECAF 34.1.2. (BSF/C3412-)

Year

2009

2010

 

Portugal

4 285

4 285

 

EC

4 285

4 285

 


Species

:

Alfonsinos

Beryx spp.

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of III, IV, V, VI, VII, VIII, IX, X, XII and XIV (ALF/3X14-)

Year

2009

2010

 

Ireland

10

10

 

Spain

74

74

 

France

20

20

 

Portugal

214

214

 

United Kingdom

10

10

 

EC

328

328

 


Species

:

Roundnose grenadier

Coryphaenoides rupestris

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of I, II, IV and Va (RNG/1245A-)

Year

2009

2010

 

Denmark

2

2

 

Germany

2

2

 

France

11

11

 

United Kingdom

2

2

 

EC

17

17

 


Species

:

Roundnose grenadier

Coryphaenoides rupestris

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of III (RNG/03-)

Year

2009

2010

 

Denmark

804

804

 

Germany

5

5

 

Sweden

41

41

 

EC

850

850

 


Species

:

Roundnose grenadier

Coryphaenoides rupestris

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of Vb, VI, VII (RNG/5B67-)

Year

2009 (8)

2010 (8)

 

Germany

7

6

 

Estonia

57

49

 

Ireland

254

216

 

Spain

63

54

 

France

3 222

2 738

 

Lithuania

74

63

 

Poland

37

32

 

United Kingdom

189

160

 

Others (9)

7

6

 

EC

3 910

3 324

 


Species

:

Roundnose grenadier

Coryphaenoides rupestris

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of VIII, IX, X, XII and XIV (RNG/8X14-)

Year

2009 (10)

2010 (10)

 

Germany

34

34

 

Ireland

7

7

 

Spain

3 734

3 734

 

France

172

172

 

Latvia

60

60

 

Lithuania

7

7

 

Poland

1 168

1 168

 

United Kingdom

15

15

 

EC

5 197

5 197

 


Species

:

Orange roughy

Hoplostethus atlanticus

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of VI (ORY/06-)

Year

2009

2010

 

Ireland

2

0

 

Spain

2

0

 

France

11

0

 

United Kingdom

2

0

 

EC

17

0

 


Species

:

Orange roughy

Hoplostethus atlanticus

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of VII (ORY/07-)

Year

2009

2010

 

Ireland

15

0

 

Spain

0

0

 

France

50

0

 

United Kingdom

0

0

 

Others

0

0

 

EC

65

0

 


Species

:

Orange roughy

Hoplostethus atlanticus

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of I, II, III, IV, V, VIII, IX, X, XII and XIV (ORY/1CX14C)

Year

2009

2010

 

Ireland

2

0

 

Spain

1

0

 

France

9

0

 

Portugal

2

0

 

United Kingdom

1

0

 

EC

15

0

 


Species

:

Blue ling

Molva dypterygia

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of II, IV and V (BLI/245-)

Year

2009

2010

 

Denmark

5

4

 

Germany

5

4

 

Ireland

5

4

 

France

28

25

 

United Kingdom

18

15

 

Others

5

4 (11)

 

EC

66

56

 


Species

:

Blue ling

Molva dypterygia

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of III (BLI/03-)

Year

2009

2010

 

Denmark

5

4

 

Germany

3

3

 

Sweden

5

4

 

EC

13

11

 


Species

:

Red seabream

Pagellus bogaraveo

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of VI, VII and VIII (SBR/678-) (12)

Year

2009

2010

 

Ireland

7

6 (13)

 

Spain

204

172 (13)

 

France

10

9 (13)

 

United Kingdom

25

22 (13)

 

Others

7

6 (13)  (14)

 

EC

253

215

 


Species

:

Red seabream

Pagellus bogaraveo

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of IX (SBR/09-) (15)

Year

2009

2010 (16)

 

Spain

722

614

 

Portugal

196

166

 

EC

918

780

 


Species

:

Red seabream

Pagellus bogaraveo

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of X (SBR/10-)

Year

2009

2010

 

Spain

10

10 (17)

 

Portugal

1 116

1 116 (17)

 

United Kingdom

10

10 (17)

 

EC

1 136

1 136 (17)

 


Species

:

Forkbeards

Phycis blennoides

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of I, II, III and IV (GFB/1234-)

Year

2009

2010

 

Germany

9

9

 

France

9

9

 

United Kingdom

13

13

 

EC

31

31

 


Species

:

Forkbeards

Phycis blennoides

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of V, VI and VII (GFB/567-)

Year

2009

2010

 

Germany

10

10

 

Ireland

260

260

 

Spain

588

588

 

France

356

356

 

United Kingdom

814

814

 

EC

2 028

2 028

 


Species

:

Forkbeards

Phycis blennoides

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of VIII and IX (GFB/89-)

Year

2009

2010

 

Spain

242

242

 

France

15

15

 

Portugal

10

10

 

EC

267

267

 


Species

:

Forkbeards

Phycis blennoides

Zone

:

Community waters and waters not under the sovereignty or jurisdiction of third countries of X and XII (GFB/1012-)

Year

2009

2010

 

France

9

9

 

Portugal

36

36

 

United Kingdom

9

9

 

EC

54

54

 


(1)  By-catches only. No directed fisheries for deep-sea sharks are permitted.

(2)  By-catches of up to 10 % of 2009 quotas are permitted.

(3)  By-catches only. No directed fisheries for deep-sea sharks are permitted.

(4)  By-catches of up to 10 % of 2009 quotas are permitted.

(5)  By-catches only. No directed fisheries for deep-sea sharks are permitted.

(6)  By-catches of up to 10 % of 2009 quotas are permitted.

(7)  By-catches only. No directed fisheries are permitted under this quota.

(8)  A maximum of 8 % of each quota may be fished in Community waters and waters not under the sovereignty or jurisdiction of third countries of VIII, IX, X, XII and XIV.

(9)  By-catches only. No directed fisheries are permitted under this quota.

(10)  A maximum of 8 % of each quota may be fished in Community waters and waters not under the sovereignty or jurisdiction of third countries of Vb, VI, VII.

(11)  By-catches only. No directed fisheries are permitted under this quota.

(12)  A minimum landing size of 30 cm (total length) shall be respected in 2009 and 35 cm (total length) in 2010. However, in 2010, 15 % of fish landed may have a minimum landing size of at least 30 cm (total length).

(13)  Up to 10 % of the 2010 quotas may be taken in December 2009.

(14)  By-catches only. No directed fisheries are permitted under this quota.

(15)  A minimum landing size of 30 cm (total length) shall be respected in 2009 and 35 cm (total length) in 2010. However, in 2010, 15 % of fish landed may have a minimum landing size of at least 30 cm (total length).

(16)  Up to 10 % of the 2010 quotas may be taken in December 2009.

(17)  Up to 10 % of the 2010 quotas may be taken in December 2009.


31.12.2008   

EN

Official Journal of the European Union

L 352/11


COUNCIL REGULATION (EC) No 1360/2008

of 2 December 2008

amending Regulation (EC) No 332/2002 establishing a facility providing medium-term financial assistance for Member States’ balances of payments

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 308 thereof,

Having regard to the proposal from the Commission, submitted following consultation with the Economic and Financial Committee,

Having regard to the opinion of the European Parliament,

Having regard to the opinion of the European Central Bank,

Whereas:

(1)

The large number of Member States currently outside the euro area affects the potential demand for Community medium-term financial assistance and, together with the evolution of the international context, calls for a significant raising of the ceiling for the outstanding amount of loans to be granted to Member States laid down in Regulation (EC) No 332/2002 (1) from EUR 12 billion to EUR 25 billion. If a revision of the ceiling were urgently needed, the relevant institutions should proceed swiftly according to their respective competences.

(2)

Regulation (EC) No 332/2002 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 332/2002 is hereby amended as follows:

In Article 1(1), the second subparagraph shall be replaced by the following:

‘The outstanding amount of loans to be granted to Member States under this facility shall be limited to EUR 25 billion in principal.’.

Article 2

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

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

Done at Brussels, 2 December 2008.

For the Council

The President

C. LAGARDE


(1)  OJ L 53, 23.2.2002, p. 1.


31.12.2008   

EN

Official Journal of the European Union

L 352/12


COUNCIL REGULATION (EC) No 1361/2008

of 16 December 2008

amending Regulation (EC) No 219/2007 on the establishment of a joint undertaking to develop the new generation European air traffic management system (SESAR)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 171 and 172 thereof,

Having regard to the proposal from the Commission,

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

Having regard to the opinion of the European Economic and Social Committee (2),

Whereas:

(1)

Since the establishment of the SESAR Joint Undertaking (Joint Undertaking), Council Regulation (EC) No 71/2008 of 20 December 2007 has set up the Clean Sky Joint Undertaking (3), Council Regulation (EC) No 72/2008 of 20 December 2007 set up the ENIAC Joint Undertaking (4), Council Regulation (EC) No 73/2008 of 20 December 2007 set up the Joint Undertaking for the implementation of the Joint Technology Initiative on Innovative Medicines (5), and Council Regulation (EC) No 74/2008 of 20 December 2007 set up the ARTEMIS Joint Undertaking to implement a Joint Technology Initiative in Embedded Computing Systems (6). Those Joint Undertakings are bodies set up by the Communities within the meaning of Article 185(1) of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (7). Regulation (EEC, Euratom, ECSC) No 259/68 of the Council of 29 February 1968 laying down the Staff Regulations of Officials and the Conditions of Employment of other Servants of the European Communities (8) applies to their staff, and the Protocol on Privileges and Immunities of the European Communities applies to them and to their staff.

(2)

As a body set up by the Communities, it is appropriate to align the legal status of the SESAR Joint Undertaking with that of the other newly established Joint Undertakings, in order to ensure that this Joint Undertaking benefits from the same treatment as that afforded to the other newly established Joint Undertakings.

(3)

Council Decision 2006/971/EC of 19 December 2006 concerning the specific programme ‘Cooperation’ implementing the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007 to 2013) (9) states that research will develop and implement an innovative Air Traffic Management (ATM) system within the context of the SESAR initiative, which will also ensure the most effective coordination of the development of the ATM systems in Europe.

(4)

According to the annual work programmes for 2007 and 2008 concerning the Specific Programme ‘Cooperation’, Transport (including aeronautics), implementing the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007 to 2013), the Commission will provide annual contributions from the Seventh Framework Programme to the SESAR Joint Undertaking for a total estimated amount of EUR 350 million over the entire programme.

(5)

The multi-annual work programme for grants in the field of trans-European Transport networks for the period 2007-2013 identifies the SESAR project to modernise ATM in Europe as a major horizontal priority by allocating to it an estimated budget of EUR 350 million over that period.

(6)

The Commission estimates that the Community’s contribution to the SESAR Joint Undertaking will be EUR 700 million, which will come in equal parts from the 7th Framework Programme for Research and Development and from the Trans-European transport networks programme.

(7)

As the Joint Undertaking is a body set up by the Communities, its decision-making process should guarantee the Community’s decision-making autonomy, in particular in respect of; issues having an impact on the strategic orientation of the Joint Undertaking, the Community’s contribution, and the independence and equal treatment of the Joint Undertaking’s staff.

(8)

An administrative agreement should be concluded between the SESAR Joint Undertaking and Belgium concerning privileges and immunities and other support to be provided by Belgium to the Joint Undertaking.

(9)

In order to ensure the efficient management of the resources provided to the Joint Undertaking for its research activities and to ensure that, as far as possible, the Joint Undertaking receives the same treatment as other comparable undertakings, it is necessary to ensure that the fiscal matters of the Protocol on Privileges and Immunities of the European Communities are applied retroactively from an appropriate date.

(10)

Regulation (EC) No 219/2007 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Amendments to Regulation (EC) No 219/2007

Regulation (EC) No 219/2007 is hereby amended as follows:

1.

in Article 1, paragraph 2 shall be replaced by the following:

‘2.   The Joint Undertaking shall cease to exist on 31 December 2016 or eight years after an endorsement by the Council of the European Air Traffic Management Master Plan (the ATM Master Plan) resulting from the definition phase of the SESAR project, whichever is the earlier. The Council shall decide on such endorsement acting on a proposal from the Commission.’;

2.

Article 2 shall be replaced by the following:

‘Article 2

Legal status

The Joint Undertaking shall be a Community body and shall have legal personality. In every Member State, it shall enjoy the most extensive legal capacity accorded to legal persons under the law of that State. It may, in particular, acquire or dispose of movable and immovable property and may be a party to legal proceedings.’;

3.

the following Articles shall be inserted:

‘Article 2a

Staff

1.   The Staff Regulations of Officials of the European Communities, the Conditions of Employment of other servants of the European Communities and the rules adopted jointly by the institutions of the European Communities for the purpose of applying these Staff Regulations and the Conditions of Employment shall apply to the staff of the Joint Undertaking and its Executive Director.

2.   Without prejudice to Article 7(2) of its Statutes, the Joint Undertaking shall exercise the powers conferred on the appointing authority by the Staff Regulations of Officials of the European Communities and on the authority empowered to conclude employment contracts by the Conditions of employment of other servants of the European Communities in respect of its staff.

3.   The Administrative Board shall, in agreement with the Commission, adopt the appropriate implementing rules referred to in Article 110(1) of the Staff Regulations of Officials of the European Communities and the Conditions of Employment of other Servants of the European Communities.

4.   The staff resources shall be determined in the establishment plan of the Joint Undertaking that will be set out in its annual budget.

5.   The staff of the Joint Undertaking shall consist of temporary agents and contract agents engaged for a fixed period that may be renewed once and for a fixed period only. The total period of engagement shall not exceed eight years and shall not in any case exceed the duration of the Joint Undertaking.

6.   All costs related to the staff shall be borne by the Joint Undertaking.

Article 2b

Privileges and immunities

1.   The Protocol on the Privileges and Immunities of the European Communities shall apply to the Joint Undertaking and, insofar as they are subject to the rules referred to in paragraph 1 of Article 2a, to its staff and its Executive Director. Insofar as taxes and customs duties are concerned, that Protocol shall apply to the Joint Undertaking as from 15 October 2008.

2.   An administrative agreement shall be concluded between the Joint Undertaking and Belgium concerning privileges and immunities and other support to be provided by Belgium to the Joint Undertaking.

Article 2c

Liability

1.   The contractual liability of the Joint Undertaking shall be governed by the relevant contractual provisions and by the law applicable to the agreement or contract in question.

2.   In the case of non-contractual liability, the Joint Undertaking shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its staff in the performance of their duties.

3.   Any payment by the Joint Undertaking in respect of the liability referred to in paragraphs 1 and 2 and the costs and expenses incurred in connection therewith shall be considered as expenditure of the Joint Undertaking and shall be covered by its resources.

4.   The Joint Undertaking shall be solely responsible for meeting its obligations.

Article 2d

Jurisdiction of the Court of Justice and applicable law

1.   The Court of Justice shall have jurisdiction:

(a)

in any dispute between the members, which relates to the subject matter of this Regulation and/or the Statutes referred to in Article 3;

(b)

pursuant to any arbitration clause contained in agreements and contracts concluded by the Joint Undertaking;

(c)

in actions brought against the Joint Undertaking, including decisions of its bodies, under the conditions provided for in Articles 230 and 232 of the Treaty;

(d)

in disputes related to compensation for damage caused by the staff of the Joint Undertaking in the performance of their duties.

2.   For any matter not covered by this Regulation or by other acts of Community law, the law of the State where the seat of the Joint Undertaking is located shall apply.’;

4.

in Article 4, paragraph 2 shall be replaced by the following:

‘2.   The maximum Community contribution shall be EUR 700 million of which EUR 350 million shall be paid from the budget appropriation allocated to the theme “Transport (Including Aeronautics)” of the Specific Programme Cooperation of the Seventh Framework Programme for research and technological development and EUR 350 million from the budget of the Framework Programme on Trans-European networks for the period 2007-2013. The Community contribution shall be paid in accordance with Article 54(2)(b) of Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities (10) (hereinafter referred to as the Financial Regulation).

The arrangements for the Community contribution shall be established by means of a general agreement and annual financial implementation agreements, which shall be concluded between the Commission, on behalf of the Community, and the Joint Undertaking.

The general agreement shall provide for a right for the Commission to oppose the use of the Community contribution for purposes it considers to be contrary to the principles of the Community programmes mentioned in the first subparagraph or to its Financial Regulation or detrimental to the interests of the Community. In the event of the Commission’s opposition, the Community contribution cannot be used by the Joint Undertaking for those purposes.

5.

the following Articles shall be inserted:

‘Article 4a

Financial Rules

1.   The Joint Undertaking shall adopt specific financial rules in accordance with Article 185(1) of the Financial Regulation. They may depart from the rules laid down in Commission Regulation (EC, Euratom) No 2343/2002 of 23 December 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of the Financial Regulation (11) where the specific operating needs of the Joint Undertaking so require and subject to prior consent of the Commission.

2.   The Joint Undertaking shall have its own internal audit capability.

Article 4b

Discharge

Discharge for the implementation of the budget of the year n of the Joint Undertaking shall be given by the European Parliament, upon recommendation from the Council, before 15 May of the year n + 2. The Administrative Board shall, in the financial rules of the Joint Undertaking, provide for the procedure to be followed when giving discharge, taking into account the particular characteristics resulting from the nature of the Joint Undertaking as public-private partnership, and in particular from the private sector contribution to the budget.

6.

in Article 5, paragraph 4 shall be replaced by the following:

‘4.   The position of the Community in the Administrative Board as regards decisions concerning the accession of new members and significant modifications of the ATM Master Plan shall be adopted in accordance with the procedure referred to in Article 6.3.’;

7.

the Annex shall be amended in accordance with the Annex to this Regulation.

Article 2

Transitional provisions related to the staff of the Joint Undertaking

1.   Notwithstanding the provisions of Article 1(3), all employment contracts concluded by the Joint Undertaking in force on 1 January 2009 (hereinafter prior contracts) shall be honoured until their expiry date without further renewal.

2.   All members of staff under prior contracts shall be offered the possibility to apply for temporary agents’ contracts under Article 2(a) of the Conditions of Employment of Other Servants of the European Communities laid down in Regulation (EEC, Euratom, ECSC) No 259/68 at the various grades as set out in the establishment plan.

In order to check the ability, efficiency and integrity of potential applicants, an internal selection process shall be applied to all staff members who have prior contracts, except the Executive Director. This internal selection process shall be carried out before 1 July 2009 by the authority authorised to conclude employment contracts.

Depending on the type and level of functions performed, successful applicants shall be offered temporary agents’ contracts of a duration corresponding at least to the time remaining under the prior contract.

3.   If a prior contract had been concluded for the duration of the Joint Undertaking and the staff member accepts a new temporary agent’s contract under the conditions set out in paragraph 2, that new contract will be concluded for an indefinite duration in accordance with the first paragraph of Article 8 of the Conditions of Employment of other Servants of the European Communities.

4.   The Belgian law applying to labour contracts and other relevant instruments shall continue to apply to staff members with prior contracts who choose not to apply for temporary agents’ contracts or who are not offered temporary agents’ contracts in accordance with paragraph 2.

Article 3

Transitional provisions related to the mandate of the Executive Director

The mandate of the Executive Director in place on 1 January 2009 shall cease on the date on which the Joint Undertaking shall cease to exist, as set out in Article 1(2) of Regulation (EC) No 219/2007. In the event of an extension of the duration of the Joint Undertaking, a new procedure leading to the appointment of the Executive Director in accordance with Article 7(2) of the Annex to Regulation (EC) No 219/2007 shall be launched. If, during his mandate, the Executive Director has to be replaced, his successor shall be appointed in accordance with Article 7(2) of the Annex to Regulation (EC) No 219/2007.

Article 4

Prior contracts and agreements

Without prejudice to Article 2, this Regulation shall not affect the rights and obligations arising from contracts and other agreements concluded by the Joint Undertaking prior to 1 January 2009.

Article 5

Entry into force

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

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

Done at Brussels, 16 December 2008.

For the Council

The President

R. BACHELOT-NARQUIN


(1)  Opinion of 18 November 2008, not yet published in the Official Journal.

(2)  Opinion of 3 December 2008, not yet published in the Official Journal.

(3)  OJ L 30, 4.2.2008, p. 1.

(4)  OJ L 30, 4.2.2008, p. 21.

(5)  OJ L 30, 4.2.2008, p. 38.

(6)  OJ L 30, 4.2.2008, p. 52.

(7)  OJ L 248, 16.9.2002, p. 1.

(8)  OJ L 56, 4.3.1968, p. 1.

(9)  OJ L 400, 30.12.2006, p. 86. Corrected by OJ L 54, 22.2.2007, p. 30.

(10)  OJ L 248, 16.9.2002, p. 1.’;

(11)  OJ L 357, 31.12.2002, p. 72.’;


ANNEX

The Statutes of the Joint Undertaking shall be amended as follows:

1.

in Article 5, paragraph 1(f) the following words shall be added at the end:

‘and monitoring the Executive Director’s performance’;

2.

in Article 5, paragraph 1(h) the words ‘financial regulations’ are replaced by ‘financial rules’;

3.

Article 7 shall be amended as follows:

(a)

in paragraph 1 the following sentence shall be added:

‘The Executive Director shall exercise, in respect of the staff, the powers laid down in Article 2a(2) of Regulation (EC) No 219/2007.’;

(b)

paragraph 2 shall be replaced by the following:

‘2.   The Executive Director shall be appointed by the Administrative Board on the basis of a list of at least three candidates proposed by the Commission following a call for expressions of interest published in the Official Journal of the European Union and in other periodicals or Internet sites. The Executive Director shall be appointed for a period of three years. After an evaluation by the Administrative Board of the Executive Director’s performance during this period, his term of office may be extended once for a further period of no more than four years. In any case the term of office may not go beyond the duration of the Joint Undertaking set out in Article 1(2) of Regulation (EC) No 219/2007.’;

(c)

paragraph 5 is amended as follows:

(i)

point (a) is replaced by the following:

‘(a)

employ, manage and supervise the staff of the Joint Undertaking, including the staff referred to in Article 8;’;

(ii)

in point (e) the words ‘Financial Regulations’ are replaced by ‘financial rules’;

4.

the following Article shall be inserted:

‘Article 7a

Internal Auditing function

The functions entrusted by Article 185(3) of the Financial Regulation to the Commission’s internal auditor shall be carried out under the responsibility of the Administrative Board, which shall make appropriate provision, taking into account the size and the scope of the Joint Undertaking.’;

5.

Article 8 shall be replaced by the following:

‘Article 8

Secondment of staff to the Joint Undertaking

Any member of the Joint Undertaking may propose to the Executive Director the secondment of members of its staff to the Joint Undertaking in accordance with conditions provided for in the relevant agreement referred to in Article 1(3) of these Statutes. Staff seconded to the Joint Undertaking must act with complete independence under the supervision of the Executive Director.’;

6.

Article 14 shall be deleted;

7.

Article 15 shall be amended as follows:

(a)

paragraph 2 is replaced by the following:

‘2.   Each year the Executive Director shall transmit to the members the cost estimates of the SESAR project as approved by the Administrative Board. The Administrative Board shall, in the financial rules of the Joint Undertaking, provide for the procedure to be followed when transmitting the cost estimates.’;

(b)

paragraph 4 is replaced by the following:

‘4.   Based on the approved project cost estimates, and taking into account the comments received from members, the Executive Director shall prepare the draft budget for the following year and, submit it to the Administrative Board for adoption. The Administrative Board shall, in the financial rules of the Joint Undertaking, provide for the procedure to be followed when submitting the draft budget.’;

8.

in Article 17, the following paragraph shall be added:

‘3.   All decisions adopted and contracts concluded by the Joint Undertaking, shall provide explicitly that OLAF and the Court of Auditors may carry out on-the-spot inspections of the documents of all contractors and sub-contractors which have received Community funds, including inspections at the premises of the final beneficiaries.’;

9.

Article 19 shall be replaced by the following:

‘Article 19

Transparency

1.   Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding access to European Parliament, Council and Commission documents (1) shall apply to documents held by the Joint Undertaking.

2.   The Joint Undertaking shall adopt practical arrangements for implementing Regulation (EC) No 1049/2001 by 1 July 2009.

3.   Decisions taken by the Joint Undertaking pursuant to Article 8 of Regulation (EC) No 1049/2001 may form the subject of a complaint to the Ombudsman or of an action before the Court of Justice, under the conditions laid down in Articles 195 and 230 of the Treaty respectively.

10.

Article 21 shall be replaced by the following:

‘Article 21

Insurance

The Executive Director shall propose to the Administrative Board to take out any necessary insurance and the Joint Undertaking shall take out such insurance as the Administrative Board may request.’;

11.

in Article 24, paragraph 2 is replaced by the following:

‘2.   If the Administrative Board agrees to the proposals referred to in paragraph 1 by a majority of 75 % of the votes and in accordance with Article 4(5) of these Statutes, these proposals shall be submitted as draft amendments to the Commission, which shall adopt them as appropriate in accordance with the procedure set out in Article 6(3) of Regulation (EC) No 219/2007.’;

12.

in Article 24, the following paragraph shall be added:

‘3.   However, any amendment affecting the essential elements of these Statutes and in particular amendments to Articles 1, 3, 4, 5, 7, 12, 17, 18, 19, 20, 22, 24 and 25 shall be adopted in accordance with Article 172 of the Treaty.’.


(1)  OJ L 145, 31.5.2001, p. 43.’.


31.12.2008   

EN

Official Journal of the European Union

L 352/18


COUNCIL REGULATION (EC) No 1362/2008

of 18 December 2008

amending Regulation (EC) No 2505/96 opening and providing for the administration of autonomous Community tariff quotas for certain agricultural and industrial products

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 26 thereof,

Having regard to the proposal from the Commission,

Whereas:

(1)

On 20 December 1996 the Council adopted Regulation (EC) No 2505/96 (1). Community demand for the products to which that Regulation applies should be met under the most favourable conditions. For that purpose with effect from 1 January 2009, one new Community tariff quota should be opened at zero rate of duty for the appropriate amount while avoiding any disturbance to the market regarding this product.

(2)

The quota amounts for two autonomous Community tariff quotas are insufficient to meet the needs of the Community industry for the current quota period ending on 31 December 2008. Consequently, those quota amounts should be increased with effect from 1 January 2008.

(3)

The quota amount for one autonomous Community tariff quota disturbs the internal market of the Community. Consequently, this quota amount should be reduced.

(4)

It is no longer in the Community interest to continue to grant Community tariff quotas in 2009 for certain products for which such quotas were established for 2008. Those quotas should therefore be closed with effect from 1 January 2009 and the corresponding products should be removed from the list in Annex I to Regulation (EC) No 2505/96.

(5)

In view of the many changes to be made, clarity requires Annex I to Regulation (EC) No 2505/96 to be replaced in its entirety.

(6)

Regulation (EC) No 2505/96 should therefore be amended accordingly.

(7)

Having regard to the economic importance of this Regulation, it is necessary to rely on the grounds of urgency provided for in point I(3) of the Protocol on the role of national parliaments in the European Union annexed to the Treaty on European Union and to the Treaties establishing the European Community.

(8)

Since the tariff quotas have to take effect from 1 January 2009, this Regulation should apply from the same date and enter into force immediately,

HAS ADOPTED THIS REGULATION:

Article 1

Annex I to Regulation (EC) No 2505/96 shall be replaced by the text set out in the Annex to this Regulation.

Article 2

With effect from 1 January 2008, in Annex I to Regulation (EC) No 2505/96:

(a)

the quota volume of the tariff quota for order number 09.2812 shall be fixed at 4 000 tonnes;

(b)

the quota volume of the tariff quota for order number 09.2950 shall be fixed at 15 000 tonnes.

Article 3

With effect from 1 January 2009, in Annex I to Regulation (EC) No 2505/96:

the quota volume for the tariff quota for order number 09.2908 shall be fixed at 40 000 tonnes.

Article 4

With effect from 1 January 2009, in Annex I to Regulation (EC) No 2505/96, a row for order number 09.2631 shall be inserted.

Article 5

With effect from 1 January 2009, in Annex I to Regulation (EC) No 2505/96, the rows for the order numbers 09.2618, 09.2713, 09.2719, 09.2771 and 09.2775 shall be deleted.

Article 6

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

This Regulation shall apply from 1 January 2009.

However, Article 2 shall apply from 1 January 2008.

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

Done at Brussels, 18 December 2008.

For the Council

The President

M. BARNIER


(1)  OJ L 345, 31.12.1996, p. 1.


ANNEX

‘ANNEX I

Order number

CN code

TARIC

Description

Quota period

Quota amount

Quota duty

09.2849

ex 0710 80 69

10

Mushrooms of the species Auricularia polytricha (uncooked or cooked by steaming or boiling), frozen, for the manufacture of prepared meals (1)  (2)

1.1.-31.12.

700 tonnes

0 %

09.2913

ex 2401 10 35

91

Natural unmanufactured tobacco, whether or not cut in regular size, having a custom value of not less than EUR 450 per 100 kg net weight, for use as binder or wrapper for the manufacture of goods falling within subheading 2402 10 00 (1)

1.1-31.12.

6 000 tonnes

0 %

ex 2401 10 70

10

ex 2401 10 95

11

ex 2401 10 95

21

ex 2401 10 95

91

ex 2401 20 35

91

ex 2401 20 70

10

ex 2401 20 95

11

ex 2401 20 95

21

ex 2401 20 95

91

09.2841

ex 2712 90 99

10

Blend of 1-alkenes containing 80 % by weight or more of 1-alkenes of a chain-length of 20 and 22 carbon atoms

1.1.-31.12.

10 000 tonnes

0 %

09.2703

ex 2825 30 00

10

Vanadium oxides and hydroxides exclusively for use in alloys (1)

1.1-31.12.

13 000 tonnes

0 %

09.2806

ex 2825 90 40

30

Tungsten trioxide

1.1.-31.12.

12 000 tonnes

0 %

09.2611

ex 2826 19 90

10

Calcium fluoride having a total content of aluminium, magnesium and sodium of 0,25 mg/kg or less, in the form of powder

1.1.-31.12.

55 tonnes

0 %

09.2837

ex 2903 49 80

10

Bromochloromethane

1.1.-31.12.

600 tonnes

0 %

09.2933

ex 2903 69 90

30

1,3-Dichlorobenzene

1.1.-31.12.

2 600 tonnes

0 %

09.2950

ex 2905 59 98

10

2-Chloroethanol, for the manufacture of liquid thioplasts of subheading 4002 99 90 (1)

1.1.-31.12.

15 000 tonnes

0 %

09.2851

ex 2907 12 00

10

O-Cresol having a purity of not less than 98,5 % by weight

1.1.-31.12.

20 000 tonnes

0 %

09.2624

2912 42 00

 

Ethylvanillin (3-ethoxy-4-hydroxybenzaldehyde)

1.1.-31.12.

600 tonnes

0 %

09.2767

ex 2910 90 00

80

Allyl glycidyl ether

1.1.-31.12.

1 500 tonnes

0 %

09.2972

2915 24 00

 

Acetic anhydride

1.1.-31.12.

20 000 tonnes

0 %

09.2769

ex 2917 13 90

10

Dimethyl sebacate

1.1.-31.12.

1 300 tonnes

0 %

09.2808

ex 2918 22 00

10

o-Acetylsalicylic acid

1.1.-31.12.

120 tonnes

0 %

09.2975

ex 2918 30 00

10

Benzophenone-3,3′:4,4′-tetracarboxylic dianhydride

1.1.-31.12.

1 000 tonnes

0 %

09.2602

ex 2921 51 19

10

o-Phenylenediamine

1.1.-31.12.

1 800 tonnes

0 %

09.2977

2926 10 00

 

Acrylonitrile

1.1.-31.12.

30 000 tonnes

0 %

09.2030

ex 2926 90 95

74

Chlorothalonil

1.1.-31.12.

1 500 tonnes

0 %

09.2002

ex 2928 00 90

30

Phenylhydrazine

1.1.-31.12.

1 000 tonnes

0 %

09.2917

ex 2930 90 13

90

Cystine

1.1.-31.12.

600 tonnes

0 %

09.2603

ex 2930 90 85

79

Bis(3-triethoxysilylpropyl)tetrasulphide

1.1.-31.12.

9 000 tonnes

0 %

09.2810

2932 11 00

 

Tetrahydrofuran

1.1-31.12.

20 000 tonnes

0 %

09.2955

ex 2932 19 00

60

Flurtamone (ISO)

1.1.-31.12.

300 tonnes

0 %

09.2812

ex 2932 29 85

77

Hexan-6-olide

1.1.-31.12.

4 000 tonnes

0 %

09.2615

ex 2934 99 90

70

Ribonucleic acid

1.1.-31.12.

110 tonnes

0 %

09.2619

ex 2934 99 90

71

2-Thienylacetonitrile

1.1.-31.12.

80 tonnes

0 %

09.2945

ex 2940 00 00

20

D-Xylose

1.1.-31.12.

400 tonnes

0 %

09.2908

ex 3804 00 90

10

Sodium lignosulphonate

1.1.-31.12.

40 000 tonnes

0 %

09.2889

3805 10 90

 

Sulphate turpentine

1.1.-31.12.

20 000 tonnes

0 %

09.2935

3806 10 10

 

Rosin and resin acids obtained from fresh oleoresins

1.1.-31.12.

280 000 tonnes

0 %

09.2814

ex 3815 90 90

76

Catalyst consisting of titanium dioxide and tungsten trioxide

1.1.-31.12.

1 600 tonnes

0 %

09.2829

ex 3824 90 97

19

Solid extract of the residual, insoluble in aliphatic solvents, obtained during the extraction of rosin from wood, having the following characteristics:

a resin acid content not exceeding 30 % by weight

an acid number not exceeding 110

and

a melting point of 100 °C or more

1.1.-31.12.

1 600 tonnes

0 %

09.2914

ex 3824 90 97

26

Aqueous solution containing not less than 40 % by weight of dry betaine-extract and between 5 % and 30 % by weight of organic or inorganic salts

1.1.-31.12.

5 000 tonnes

0 %

09.2986

ex 3824 90 97

76

Mixture of tertiary amines containing:

60 % by weight of dodecyldimethylamine, or more

20 % by weight of dimethyl(tetradecyl)amine, or more

0,5 % by weight of hexadecyldimethylamine, or more

for use in the production of amine oxides (1)

1.1-31.12.

14 315 tonnes

0 %

09.2907

ex 3824 90 97

86

Mixture of phytosterols, in the form of powder, containing by weight:

75 % or more of sterols

not more than 25 % of stanols

for use in the manufacture of stanol/sterol esters (1)

1.1.-31.12.

2 500 tonnes

0 %

09.2140

ex 3824 90 97

98

Mixture of tertiary amines containing by weight:

2,0-4,0 % of N,N-dimethyl-1-octanamine

94 % minimum of N,N-dimethyl-1-decanamine

2 % maximum of N,N-dimethyl-1-dodecanamine

1.1.-31.12.

4 500 tonnes

0 %

09.2992

ex 3902 30 00

93

Propylene-butylene copolymer, containing by weight 60 % or more but not more than 68 % of propylene and 32 % or more but not more than 40 % of butylene, of a melt viscosity of not more than 3 000 mPa at 190 °C, as determined by the ASTM D 3236 method, for use as an adhesive in the manufacture of products falling within subheading 4818 40 (1)

1.1.-31.12.

1 000 tonnes

0 %

09.2947

ex 3904 69 90

95

Poly(vinylidene fluoride), in powder form, for the preparation of paint or varnish for coating metal (1)

1.1.-31.12.

1 300 tonnes

0 %

09.2604

ex 3905 30 00

10

Poly(vinyl alcohol) partially acetalized with 5-(4-azido-2-sulphobenzylidene)-3-(formylpropyl)-rhodanine, sodium salt

1.1.-31.12.

100 tonnes

0 %

09.2616

ex 3910 00 00

30

Polydimethylsiloxane with a degree of polymerisation of 2 800 monomer units (± 100)

1.1.-31.12.

1 300 tonnes

0 %

09.2816

ex 3912 11 00

20

Cellulose acetate flakes for use in the manufacture of cellulose acetate filament tow (1)

1.1.-31.12.

45 500 tonnes

0 %

09.2818

ex 6902 90 00

10

Refractory bricks with:

an edge length of more than 300 mm and

a TiO2 content of not more than 1 % by weight and

a Al2O3 content of not more than 0,4 % by weight and

a change in volume of less than 9 % at 1 700 °C

1.1.-31.12.

75 tonnes

0 %

09.2628

ex 7019 52 00

10

Glass web woven from glass fibre coated in plastic, of a weight of 120 g/m2 (± 10 g/m2, of a type used in rolling insect screens with fixed frames

1.1.-31.12.

350 000 m2

0 %

09.2799

ex 7202 49 90

10

Ferro-chromium containing 1,5 % or more but not more than 4 % by weight of carbon and not more than 70 % of chromium

1.1.-31.12.

50 000 tonnes

0 %

09.2629

ex 7616 99 90

85

Aluminium telescopic handle for use in the manufacture of luggage (1)

1.1.-31.12.

240 000 units

0 %

09.2763

ex 8501 40 80

30

Electric AC commutator motor, single-phase, with an output of more than 750 W, an input power of more than 1 600 W but not more than 2 700 W, an external diameter of more than 120 mm (± 0,2 mm) but not more than 135 mm (± 0,2 mm), a rated speed of more than 30 000 rpm but not more than 50 000 rpm, equipped with air-inducting ventilator, for use in the manufacture of vacuum cleaners (1)

1.1.-31.12.

2 000 000 units

0 %

09.2620

ex 8526 91 20

20

Assembly for GPS system having a position determination function

1.1.-31.12.

2 000 000 units

0 %

09.2003

ex 8543 70 90

63

Voltage controlled frequency generator, consisting of active and passive elements mounted on a printed circuit, contained in a housing with dimensions of not more than 30 × 30 mm

1.1.-31.12.

1 400 000 units

0 %

09.2631

ex 9001 90 00

80

Unmounted glass lenses, prisms and cemented elements for use in the manufacture of goods of CN codes 9005, 9013 and 9015 (1)

1.1.-31.12.

5 000 000 units

0 %


(1)  Entry under this subheading is subject to conditions laid down in the relevant Community provisions (see Articles 291 to 300 of Commission Regulation (EEC) No 2454/93 (OJ L 253, 11.10.1993, p. 1)).

(2)  However, the measure is not allowed where processing is carried out by retail or catering undertakings.’


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

DECISIONS

Council

31.12.2008   

EN

Official Journal of the European Union

L 352/23


COUNCIL DECISION

of 18 December 2008

on the signing on behalf of the Community and the provisional application of the Agreement between the European Community and the Swiss Confederation amending Annex 11 to the Agreement between the European Community and the Swiss Confederation on trade in agricultural products

(2008/979/EC)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Articles 37, 133 and 152(4)(b), in conjunction with the first subparagraph of Article 300(2) thereof,

Having regard to the proposal from the Commission,

Whereas:

(1)

On 25 October 2004 the Council authorised the Commission to open negotiations with the Swiss Confederation with a view to updating and adapting the Agreement between the European Community and the Swiss Confederation on trade in agricultural products.

(2)

The Community and the Swiss Confederation have negotiated an Agreement amending Annex 11 to the said Agreement.

(3)

The Agreement between the European Community and the Swiss Confederation amending Annex 11 to the Agreement between the European Community and the Swiss Confederation on trade in agricultural products should be signed and applied on a provisional basis from 1 January 2009 pending the completion of the procedures for its formal conclusion,

HAS DECIDED AS FOLLOWS:

Article 1

The signing of the Agreement between the European Community and the Swiss Confederation amending Annex 11 to the Agreement between the European Community and the Swiss Confederation on trade in agricultural products, and the Final Act thereto, is hereby approved on behalf of the Community, subject to the conclusion of the said Agreement.

The text of the Agreement is attached to this Decision.

Article 2

The President of the Council is hereby authorised to designate the person(s) empowered to sign the Agreement, and the Final Act thereto, on behalf of the Community, subject to its conclusion.

Article 3

Pending the completion of the procedures required for its conclusion, the Agreement shall apply provisionally from 1 January 2009 in accordance with Article 2 thereof.

Article 4

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

Done at Brussels, 18 December 2008.

For the Council

The President

M. BARNIER


AGREEMENT

between the European Community and the Swiss Confederation amending Annex 11 to the Agreement between the European Community and the Swiss Confederation on trade in agricultural products

THE EUROPEAN COMMUNITY,

hereinafter referred to as ‘the Community’,

and

THE SWISS CONFEDERATION,

hereinafter referred to as ‘Switzerland’,

together referred to hereinafter as ‘the Parties’,

Whereas:

(1)

The Agreement between the European Community and the Swiss Confederation of 21 June 1999 on trade in agricultural products, hereinafter referred to as ‘the Agreement’, entered into force on 1 June 2002.

(2)

Annex 11 to the Agreement, hereinafter referred to as ‘Annex 11’, concerns animal health and zootechnical measures applicable to trade in live animals and animal products.

(3)

Switzerland has undertaken to include in its national legislation the provisions of Regulation (EC) No 998/2003 of the European Parliament and of the Council of 26 May 2003 on the animal health requirements applicable to the non-commercial movement of pet animals and amending Council Directive 92/65/EEC (1). Consequently, the Parties have to amend the Agreement to take account of the fact that its scope has been extended to include the non-commercial movement of pet animals.

(4)

Switzerland has undertaken to include in its national legislation the provisions of Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC (2), of Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (3), of Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (4), 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), and all the provisions adopted for their implementation in the control of imports from third countries into the European Union and, as a result, the Parties have to adapt the provisions of the Agreement.

(5)

The Joint Veterinary Committee does not have the powers to make the amendments and adjustments required as a result of changes to the respective legislation. Annex 11 to the Agreement therefore needs to be updated and amended,

HAVE AGREED ON THE FOLLOWING PROVISIONS:

Article 1

1.   A third indent shall be added to the end of Article 1(1) of Annex 11:

‘—

non-commercial movements of pet animals.’.

2.   The title of Title I of Annex 11 shall be replaced by the following:

‘Trade in live animals, their semen, ova and embryos and the non-commercial movement of pet animals’.

3.   The following shall be substituted for Article 3 of Title I of Annex 11:

‘Article 3

The Parties hereby agree that trade in live animals, their semen, ova and embryos and the non-commercial movement of pet animals shall be carried out in accordance with the legislation specified in Appendix 2. That legislation shall apply subject to the special rules and procedures laid down in that Appendix.’.

4.   The following shall be substituted for Article 15 of Annex 11:

‘Article 15

Animal products: border checks and payment of fees

Checks on trade in animal products between the Community and Switzerland shall be carried out in accordance with Appendix 10.’.

Article 2

This Agreement shall be ratified or approved by the Parties in accordance with their internal procedures.

The Parties shall notify each other of the completion of these procedures.

This Agreement shall apply provisionally from 1 January 2009 pending the completion of those procedures.

This Agreement shall enter into force on the day following the last notification.

Article 3

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

In witness whereof, the undersigned Plenipotentiaries have hereunto set their hands.

Съставен в Париж на двадесет и трети декември две хиляди и осма година.

Hecho en París, el veintitrés de diciembre de dos mil ocho.

V Paříži dne dvacátého třetího prosince dva tisíce osm.

Udfærdiget i Paris, den treogtyvende december to tusind og otte

Geschehen zu Paris am dreiundzwanzigsten Dezember zweitausendacht.

Sõlmitud kahekümne kolmandal detsembril kahe tuhande kaheksandal aastal Pariisis.

Έγινε στο Παρίσι, στις είκοσι τρεις Δεκεμβρίου δύο χιλιάδες οκτώ.

Done at Paris, on the twenty-third day of December in the year two thousand and eight.

Fait à Paris, le vingt-trois décembre deux mil huit.

Fatto a Parigi, addì ventitré di dicembre duemilaotto

Parīzē, divtūkstoš astotā gada divdesmit trešajā decembrī.

Priimta Paryžiuje du tūkstančiai aštuntųjų metų gruodžio dvidešimt trečią dieną.

Kelt Párizsban, a kétezer-nyolcadik év december havának huszonharmadik napján.

Magħmul f'Pariġi, fit-tlieta u għoxrin jum ta' Diċembru elfejn u tmienja.

Gedaan te Parijs op drieëntwintig december tweeduizendacht.

Sporządzono w Paryżu dnia dwudziestego trzeciego grudnia dwa tysiące ósmego roku.

Feito em Paris, aos vinte e três de Dezembro de dois mil e oito.

Încheiat la Paris, la douăzeci și trei decembrie două mii opt.

V Paríži dvadsiateho tretieho decembra dvetisícosem

Sestavljeno v Parizu, triindvajsetega decembra leta dva tisoč osem.

Tehty Pariisissa kahdentenakymmenentenäkolmantena päivänä joulukuuta vuonna kaksituhattakahdeksan.

Undertecknat i Paris den tjugotredje december tjugohundraåtta.

За Европейската общност

Por la Comunidad Europea

Za Evropské společenství

For Det Europæiske Fællesskab

Für die Europäische Gemeinschaft

Euroopa Ühenduse nimel

Για την Ευρωπαϊκή Κοινότητα

For the European Community

Pour la Communauté européenne

Per la Comunità europea

Eiropas Kopienas vārdā

Europos bendrijos vārdā

az Európai Közösség részéről

Għall-Komunità Ewropea

Voor de Europese Gemeenschap

W imieniu Wspólnoty Europejskiej

Pela Comunidade Europeia

Pentru Comunitatea Europeană

Za Európske spoločenstvo

Za Evropsko skupnost

Euroopan yhteisön puolesta

På Europeiska gemenskapens vägnar

Image

Image

За Конфедерация Швейцария

Por la Confederación Suiza

Za Švýcarskou konfederaci

For Det Schweiziske Forbund

Für die Schweizerische Eidgenossenschaft

Šveitsi Konföderatsiooni nimel

Για την Ελβετική Συνομοσπονδία

For the Swiss Confederation

Pour la Confédération suisse

Per la Confederazione svizzera

Šveices Konfederācijas vārdā

Šveicarijos Konfederacijos vardu

a Svájci Államszövetség részéről

Għall-Konfederazzjoni Żvizzera

Voor de Zwitserse Bondsstaat

W imieniu Konfederacji Szwajcarskiej

Pela Confederação Suíça

Pentru Confederația Elvețiană

Za Švajčiarsku konfederáciu

Za Švicarsko konfederacijo

Sveitsin valaliiton puolesta

På Schweiziska edsförbundets vägnar

Image


(1)  OJ L 146, 13.6.2003, p. 1.

(2)  OJ L 268, 24.9.1991, p. 56.

(3)  OJ L 24, 30.1.1998, p. 9.

(4)  OJ L 18, 23.1.2003, p. 11.

(5)  OJ L 165, 30.4.2004, p. 1.

FINAL ACT

The representatives of

THE EUROPEAN COMMUNITY,

of the one part, and of

THE SWISS CONFEDERATION,

of the other part,

meeting on the twenty-third day of December in the year two thousand and eight in Paris for the signature of the Agreement between the European Community and the Swiss Confederation amending Annex 11 to the Agreement between the European Community and the Swiss Confederation on trade in agricultural products, have adopted the Declaration by Switzerland set out below and attached to this Final Act:

Declaration by Switzerland on the importation of meat produced using hormones to boost animal performance.

Съставен в Париж на двадесет и трети декември две хиляди и осма година.

Hecho en París, el veintitrés de diciembre de dos mil ocho.

V Paříži dne dvacátého třetího prosince dva tisíce osm.

Udfærdiget i Paris, den treogtyvende december to tusind og otte

Geschehen zu Paris am dreiundzwanzigsten Dezember zweitausendacht.

Sõlmitud kahekümne kolmandal detsembril kahe tuhande kaheksandal aastal Pariisis.

Έγινε στο Παρίσι, στις είκοσι τρεις Δεκεμβρίου δύο χιλιάδες οκτώ.

Done at Paris, on the twenty-third day of December in the year two thousand and eight.

Fait à Paris, le vingt-trois décembre deux mil huit.

Fatto a Parigi, addì ventitré di dicembre duemilaotto

Parīzē, divtūkstoš astotā gada divdesmit trešajā decembrī.

Priimta Paryžiuje du tūkstančiai aštuntųjų metų gruodžio dvidešimt trečią dieną.

Kelt Párizsban, a kétezer-nyolcadik év december havának huszonharmadik napján.

Magħmul f'Pariġi, fit-tlieta u għoxrin jum ta' Diċembru elfejn u tmienja.

Gedaan te Parijs op drieëntwintig december tweeduizendacht.

Sporządzono w Paryżu dnia dwudziestego trzeciego grudnia dwa tysiące ósmego roku.

Feito em Paris, aos vinte e três de Dezembro de dois mil e oito.

Încheiat la Paris, la douăzeci și trei decembrie două mii opt.

V Paríži dvadsiateho tretieho decembra dvetisícosem

Sestavljeno v Parizu, triindvajsetega decembra leta dva tisoč osem.

Tehty Pariisissa kahdentenakymmenentenäkolmantena päivänä joulukuuta vuonna kaksituhattakahdeksan.

Undertecknat i Paris den tjugotredje december tjugohundraåtta.

За Европейската общност

Por la Comunidad Europea

Za Evropské společenství

For Det Europæiske Fællesskab

Für die Europäische Gemeinschaft

Euroopa Ühenduse nimel

Για την Ευρωπαϊκή Κοινότητα

For the European Community

Pour la Communauté européenne

Per la Comunità europea

Eiropas Kopienas vārdā

Europos bendrijos vārdā

az Európai Közösség részéről

Għall-Komunità Ewropea

Voor de Europese Gemeenschap

W imieniu Wspólnoty Europejskiej

Pela Comunidade Europeia

Pentru Comunitatea Europeană

Za Európske spoločenstvo

Za Evropsko skupnost

Euroopan yhteisön puolesta

På Europeiska gemenskapens vägnar

Image

Image

За Конфедерация Швейцария

Por la Confederación Suiza

Za Švýcarskou konfederaci

For Det Schweiziske Forbund

Für die Schweizerische Eidgenossenschaft

Šveitsi Konföderatsiooni nimel

Για την Ελβετική Συνομοσπονδία

For the Swiss Confederation

Pour la Confédération suisse

Per la Confederazione svizzera

Šveices Konfederācijas vārdā

Šveicarijos Konfederacijos vardu

a Svájci Államszövetség részéről

Għall-Konfederazzjoni Żvizzera

Voor de Zwitserse Bondsstaat

W imieniu Konfederacji Szwajcarskiej

Pela Confederação Suíça

Pentru Confederația Elvețiană

Za Švajčiarsku konfederáciu

Za Švicarsko konfederacijo

Sveitsin valaliiton puolesta

På Schweiziska edsförbundets vägnar

Image

DECLARATION BY SWITZERLAND

on the importation of meat produced using hormones to boost animal performance

Switzerland declares that it will take due account of the final decision of the World Trade Organisation (WTO) as regards the possibility of prohibiting the importation of meat produced using hormones to boost animal performance, and that it will accordingly review its rules governing the importation of meat from countries which do not prohibit the use of hormones to boost animal performance, and if necessary align them on the relevant Community rules.


Commission

31.12.2008   

EN

Official Journal of the European Union

L 352/31


COMMISSION DECISION

of 5 December 2008

appointing members and alternates of the Committee for Advanced Therapies to represent clinicians and patients associations

(Text with EEA relevance)

(2008/980/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (1), and in particular Article 21(1) thereof,

Whereas:

(1)

Regulation (EC) No 1394/2007 lays down specific rules concerning the authorisation, supervision and pharmacovigilance of advanced therapy medicinal products. Article 20 of that Regulation lays down that a Committee for Advanced Therapies shall be established within the European Medicines Agency.

(2)

Subparagraph (c) of Article 21(1) of Regulation (EC) No 1394/2007 lays down that the Committee for Advanced Therapies shall include two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consulting the European Parliament, in order to represent clinicians.

(3)

Subparagraph (d) of Article 21(1) of Regulation (EC) No 1394/2007 lays down that the Committee for Advanced Therapies shall include two members and two alternates appointed by the Commission, on the basis of a public call for expressions of interest and after consulting the European Parliament, in order to represent patients associations.

(4)

In accordance with Article 21(1) of Regulation (EC) No 1394/2007, a public call for expressions of interest has been undertaken by the Commission. The European Parliament has also been consulted on the results of the evaluation of the applications received.

(5)

The members and alternates of the Committee for Advanced Therapies should be appointed for a period of three years, starting on the date of application of Regulation (EC) No 1394/2007,

HAS DECIDED AS FOLLOWS:

Article 1

The following are hereby appointed members and alternates of the Committee for Advanced Therapies to represent clinicians for a term of three years, from 30 December 2008:

Dietger Niederwieser (Member) and Per Ljungman (Alternate),

George Dickson (Member) and Thierry VandenDriessche (Alternate).

Article 2

The following are hereby appointed members and alternates of the Committee for Advanced Therapies to represent patients associations for a term of three years, from 30 December 2008:

Fabrizia Bignami (Member) and Michele Lipucci di Paola (Alternate),

Alastair Kent (Member) and Nicholas Meade (Alternate).

Done at Brussels, 5 December 2008.

For the Commission

Günter VERHEUGEN

Vice-President


(1)  OJ L 324, 10.12.2007, p. 121.


31.12.2008   

EN

Official Journal of the European Union

L 352/32


COMMISSION DECISION

of 5 December 2008

extending the derogations from certain provisions of Council Directive 91/440/EEC and Directive 2001/14/EC of the European Parliament and of the Council granted to Ireland and the United Kingdom in respect of Northern Ireland

(notified under document number C(2008) 7703)

(Only the English text is authentic)

(2008/981/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 91/440/EEC of 29 July 1991 on the development of the Community’s railways (1), and in particular Article 14a(3) thereof, as well as to Directive 2001/14/EC of the European Parliament and of the Council of 26 February 2001 on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (2), and in particular Article 33(3) thereof,

Whereas:

(1)

According to Article 14a of Directive 91/440/EEC and to Article 33 of Directive 2001/14/EC, Ireland and the United Kingdom in respect of Northern Ireland benefit, due to their specific geographical situation, of derogations from implementing certain provisions of these Directives such as the requirements to entrust to an independent body the functions of determining equitable and non-discriminatory access to infrastructure, to set up an independent regulatory body, provisions related to capacity rights, framework agreements and measures in case of saturation of the rail network as well as other provisions. These derogations expired on 14 March 2008.

(2)

Ireland requested an extension of the derogations for a further five years on 13 March 2007 and the United Kingdom made the same request on 14 March 2007.

(3)

Based on evidence provided from the concerned Member States the Commission concluded that the specific geographical situation of Ireland and Northern Ireland and, at this stage, the lack of development prospects for rail freight services and international rail passenger services would justify extending the derogations by another five years. In the coming years, the potential cost of complying with the requirements of the Directives covered by the derogations would outweigh the potential benefits of a full implementation of the regulatory framework for a Community-wide market for rail transport services.

(4)

Several requests by the Commission for further substantiation of the requests and delays in their provision have led to a delay in the establishment of this Decision. The Decision extending the derogations granted to Ireland and the United Kingdom, in respect of Northern Ireland, should take retroactive effect from 15 March 2008.

(5)

The measures provided for in this Decision are in accordance with the opinion of the Developing European Railways Committee, set up by Article 11a of Directive 91/440/EEC and by Article 35 of Directive 2001/14/EC,

HAS ADOPTED THIS DECISION:

Article 1

The derogation granted to Ireland and the United Kingdom, in respect of Northern Ireland, referred to in Article 14a(1) of Directive 91/440/EEC is extended until 14 March 2013.

Article 2

The derogation granted to Ireland and the United Kingdom, in respect of Northern Ireland, referred to in Article 33(1) of Directive 2001/14/EC is extended until 14 March 2013.

Article 3

This Decision shall apply from 15 March 2008.

Article 4

This Decision is addressed to Ireland and the United Kingdom of Great Britain and Northern Ireland.

Done at Brussels, 5 December 2008.

For the Commission

Antonio TAJANI

Vice-President


(1)  OJ L 237, 24.8.1991, p. 25.

(2)  OJ L 75, 15.3.2001, p. 29.


31.12.2008   

EN

Official Journal of the European Union

L 352/34


COMMISSION DECISION

of 8 December 2008

authorising the United Kingdom to conclude an agreement with the Bailiwick of Jersey, the Bailiwick of Guernsey and the Isle of Man for transfers of funds between the United Kingdom and each of these territories to be treated as transfers of funds within the United Kingdom, pursuant to Regulation (EC) No 1781/2006 of the European Parliament and of the Council

(notified under document number C(2008) 7812)

(Only the English text is authentic)

(2008/982/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 1781/2006 of the European Parliament and of the Council of 15 November 2006 on information on the payer accompanying transfers of funds (1), and in particular Article 17 thereof,

Having regard to the application from the United Kingdom,

Whereas:

(1)

On 15 December 2006, the United Kingdom requested a derogation under Article 17 of Regulation (EC) No 1781/2006 for the transfers of funds between the Bailiwick of Jersey, the Bailiwick of Guernsey, the Isle of Man and the United Kingdom.

(2)

In accordance with Article 17(2) of Regulation (EC) No 1781/2006, transfers of funds between the Bailiwick of Jersey, the Bailiwick of Guernsey, the Isle of Man respectively and the United Kingdom have been provisionally treated as transfers of funds within the United Kingdom from 1 January 2007.

(3)

Member States were informed at the meeting of the Committee for the Prevention of Money Laundering and Terrorist Financing of 18 April 2008 that the Commission considered that it had received the information necessary for appraising the request made by the United Kingdom.

(4)

The Bailiwick of Jersey, the Bailiwick of Guernsey, and the Isle of Man do not form part of the territory of the Community as determined in accordance with Article 299 of the EC Treaty but form part of the currency area of the United Kingdom and therefore comply with the criterion set out in Article 17(1)(a) of Regulation (EC) No 1781/2006.

(5)

Payment services providers in the Bailiwick of Jersey, the Bailiwick of Guernsey and the Isle of Man participate directly in payment and settlement systems in the United Kingdom, and will participate in the future ‘faster payments’ system. They therefore comply with the criterion set out in Article 17(1)(b) of Regulation (EC) No 1781/2006.

(6)

The Bailiwick of Jersey, the Bailiwick of Guernsey and the Isle of Man respectively have incorporated into their legal orders provisions corresponding to those of Regulation (EC) No 1781/2006 in particular through the ‘Community provisions (wire transfers) (Jersey) Regulations 2007’, the ‘Transfers of funds ordinances for Guernsey, Sark and Alderney (Bailiwick of Guernsey)’, the ‘Isle of Man’s European Communities (Wire Transfers Regulation) (application) Order 2007’ and the ‘Isle of Man’s EC Wire Transfer Regulations 2007’.

(7)

The Money Laundering (Jersey) Order 2008 supplemented by the Handbook for the prevention and detection of money laundering and the financing of terrorism, the Bailiwick of Guernsey’s Criminal Justice (Proceeds of Crime) Regulations 2007 supplemented by the Handbook for financial services businesses on countering financial crime and terrorist financing, and the Isle of Man’s Criminal Justice (Money Laundering) Code 2007 supplemented by the Anti-money laundering guidance notes handbook, respectively contribute to the building of a sound anti-money laundering regime in these three jurisdictions.

(8)

The Terrorism (United Nations Measures) (Channel Islands) Order 2001 (SI 2001 No 3363) and The Terrorism (United Nations Measures) (Isle of Man) Order 2001 (SI 2001 No 3364) as well as the Al-Qa’ida and Taliban (United Nations Measures) (Channel Islands) Order 2002 (SI 2002 No 258) and Al-Qa’ida and Taliban (United Nations Measures) (Isle of Man) Order 2002 (SI 2002 No 259), in combination with the use of a consolidated list of asset freeze targets issued by the United Kingdom which covers the financial sanctions targets listed by the United Nations, the European Union and the United Kingdom, ensure that appropriate measures are in place in the Bailiwick of Jersey, the Bailiwick of Guernsey and the Isle of Man to impose financial penalties vis-à-vis entities or persons listed by the United Nations or the European Union.

(9)

Therefore, the Bailiwick of Jersey, the Bailiwick of Guernsey and the Isle of Man have adopted the same rules as those established under Regulation (EC) No 1781/2006 and require their respective payment services providers to apply them, thus fulfilling the criterion set out in Article 17(1)(c) of that Regulation.

(10)

It is therefore appropriate to grant to the United Kingdom the requested derogation.

(11)

The measures provided for in this Decision are in accordance with the opinion of the Committee on the Prevention of Money Laundering and Terrorist Financing,

HAS ADOPTED THIS DECISION:

Article 1

The United Kingdom shall be authorised to conclude agreements with the Bailiwick of Jersey, the Bailiwick of Guernsey and the Isle of Man respectively, to the effect that the transfers of funds between the Bailiwick of Jersey, the Bailiwick of Guernsey, the Isle of Man respectively and the United Kingdom are treated as transfers of funds within the United Kingdom for the purposes of Regulation (EC) No 1781/2006.

Article 2

This Decision is addressed to the United Kingdom of Great Britain and Northern Ireland.

Done at Brussels, 8 December 2008.

For the Commission

Charlie McCREEVY

Member of the Commission


(1)  OJ L 345, 8.12.2006, p. 1.


31.12.2008   

EN

Official Journal of the European Union

L 352/36


COMMISSION DECISION

of 9 December 2008

authorising the United Kingdom to benefit from a provision laid down in point 8.5 of Annex IIA to Council Regulation (EC) No 40/2008 as regards a fishing effort pool system for trawlers and similar fishing vessels operating in the North Sea and to the west of Scotland

(notified under document number C(2008) 7801)

(Only the English text is authentic)

(2008/983/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 40/2008 of 16 January 2008 fixing for 2008 the fishing opportunities and associated conditions for certain fish stocks and groups of fish stocks, applicable in Community waters and, for Community vessels, in waters where catch limitations are required (1), and in particular the second subparagraph of point 8.7 of Annex IIA thereto,

Having regard to the request made by the United Kingdom,

Whereas:

(1)

Points 8 and 14 of Annex IIA to Regulation (EC) No 40/2008 specify the maximum allowable fishing effort by defining maximum number of days at sea for which Community vessels of length overall equal to or greater than 10 metres carrying on board certain types of gear may be present within certain areas ranging from the Kattegat to the west of Scotland.

(2)

Point 8.5 of that Annex enables a Member State to manage, during the 2008 management period, its fishing effort allocations according to a kilowatt-day system. Such a management system allows allocating to fishing vessels a maximum number of days at sea different from those set out in that Annex, provided that the overall amounts of kilowatt-days corresponding to the combination of gear grouping and operational area to which the vessels belong is respected.

(3)

Point 8.6 of that Annex specifies that such a reallocation of days at sea shall be made with a view to a more efficient use of fishing opportunities or in order to stimulate fishing practices that lead to reduced discards and lower fishing mortality of both juvenile and adult fish.

(4)

Point 8.7 of that Annex provides the level of data detail that is requested from a Member State wishing to obtain the Commission’s authorisation for implementing such an alternative fishing effort management system.

(5)

The United Kingdom has submitted a request to the Commission with letters dated 14 April, 2 May and 22 July, and with electronically formatted reports sent May, August and September 2008 as regards such an alternative management system in the United Kingdom, applying to fishing vessels using trawls or Danish seines with a mesh size of either between 70 and 89 mm or of 100 mm and more, operating in EC waters of the Norwegian Sea, the North Sea or to the west of Scotland (ICES areas IIa, IVa to IVc or VIa). That request and reports contained the information and data required under point 8.7 of Annex IIA to Regulation (EC) No 40/2008, in particular about the scope, outline, calculation, operation, monitoring and evaluation of that system.

(6)

The United Kingdom’s system applies initially to 867 vessels. Their aggregated effort maxima during the 2008 management period are 21 095 690 kilowatt-days for the gear groupings in the range of 70 to 89 mm mesh size operating in any of the areas mentioned, and 27 867 735 kilowatt-days for the gear groupings in a range of 100 mm or more mesh size operating in any of the areas mentioned. In view of the lower amount of days at sea available to the gear groupings of mesh sizes ranging from 100 mm when operating to the west of Scotland, a sub-ceiling of 24 622 862 kilowatt-days is applicable to their fishing trips to the west of Scotland. Therefore, the conditions provided for in point 8.5 of Annex IIA to Regulation (EC) No 40/2008 are fulfilled by that system.

(7)

The Commission has evaluated that system and concluded that it serves the objectives set out in point 8.6 of Annex IIA to Regulation (EC) No 40/2008. The system reallocates the days with a view to more efficient use of fishing opportunities and in order to stimulate fishing practices that lead to reduced discards and lower fishing mortality of both juvenile and adult fish as required under that point. Moreover, under that system, the participating vessels are obliged to support specific conservation measures. These differ slightly in concept and importance according to the regions, and comprise the following components: respecting real-time area closures that have been established upon the detection of cod aggregations; using larger square mesh panels in order to increase whitefish selectivity; taking part in trials for more selective gears; and using only one gear instead of several during a trip. The impact of these measures will have to be evaluated at a later stage.

(8)

One of the incentives for fishermen to participate in the system is the allocation of steady effort compared to the management period 2007, known as ‘conservation credits’ in Scotland, despite the reduction in maximum number of days at sea that apply to trawlers in the North Sea and to the west of Scotland for the management period 2008.

(9)

Therefore the United Kingdom’s effort pool system of management in EC waters of ICES areas IIa, IVa to IVc and VIa, fishing effort of trawls, Danish seines and similar gears, except beam trawls, of mesh size either equal to or larger than 70 mm and less than 90 mm or equal to or larger than 100 mm by way of allocating and monitoring kilowatt-days should be authorised for the management period 2008,

HAS ADOPTED THIS DECISION:

Article 1

The United Kingdom’s effort pool system of management in EC waters of ICES areas IIa, IVa to IVc and VIa, fishing effort of trawls, Danish seines and similar gears, except beam trawls, of mesh size either equal to or larger than 70 mm and less than 90 mm or equal to or larger than 100 mm by way of allocating and monitoring kilowatt-days, submitted on 14 April, 2 May and 22 July 2008, is hereby authorised for the management period 2008.

Article 2

This Decision is addressed to the United Kingdom of Great Britain and Northern Ireland.

Done at Brussels, 9 December 2008.

For the Commission

Joe BORG

Member of the Commission


(1)  OJ L 19, 23.1.2008, p. 1.


31.12.2008   

EN

Official Journal of the European Union

L 352/38


COMMISSION DECISION

of 10 December 2008

amending Annex C to Council Directive 64/432/EEC and Decision 2004/226/EC as regards diagnostic tests for bovine brucellosis

(notified under document number C(2008) 7642)

(Text with EEA relevance)

(2008/984/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (1), and in particular Article 6(2)(b) and the second subparagraph of Article 16 thereof,

Whereas:

(1)

Annex C to Directive 64/432/EEC sets out the diagnostic methods for bovine brucellosis to be used for the control and eradication of that disease and for surveillance and monitoring, as well as for the establishment and maintenance of an officially brucellosis–free herd status and certification required for intra-Community trade in bovine animals.

(2)

Commission Decision 2004/226/EC of 4 March 2004 approving tests for the detection of antibodies against bovine brucellosis within the framework of Council Directive 64/432/EEC (2) approves certain tests for bovine brucellosis that may be used as an alternative to the mandatory serum agglutination test (SAT) for certification of bovine animals in accordance with Article 6(2)(b) of Directive 64/432/EEC.

(3)

The fluorescence polarisation assay (FPA) is a new diagnostic test that has been included as a prescribed test for international trade in Chapter 2.4.3 (bovine brucellosis) of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Sixth Edition, 2008 of the World Organisation for Animal Health (OIE).

(4)

The Commission requested the European Food Safety Authority (EFSA) to provide a scientific opinion on the suitability of the FPA for inclusion in Annex C to Directive 64/432/EEC.

(5)

In addition, the Commission asked EFSA to assess the suitability of the FPA and the tests listed in Article 1 of Decision 2004/226/EC for the purpose of certification of bovine animals for intra-Community trade.

(6)

On 11 December 2006, the Panel on animal health and welfare adopted a scientific opinion on brucellosis diagnostic methods for bovines (3), in which it concluded that, except the SAT, the diagnostic tests for bovine brucellosis, included in Annex C to Directive 64/432/EEC are suitable to remain as standard tests for the purpose of certification of individual bovine animals for intra-Community trade.

(7)

However, as the SAT is the pre-movement test for trade in cattle directly prescribed in Article 6(2)(b) of Directive 64/432/EEC, a technical specification must be available in Annex C to that Directive.

(8)

In addition, the scientific opinion of 11 December 2006 concluded that the sensitivity and specificity of the FPA are comparable to those of tests included in Annex C to Directive 64/432/EEC and was also found to be suitable for inclusion in that Annex as a standard test for brucellosis diagnosis in such animals for intra-Community trade.

(9)

The recently developed polymerase chain reaction methods as described in Section 1(d) of Chapter 2.4.3 of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Sixth Edition, 2008 of the OIE provide additional means of detection and identification of Brucella spp. and should therefore be included in Annex C to Directive 64/432/EEC.

(10)

Annex C to Directive 64/432/EEC and Decision 2004/226/EC should therefore be amended accordingly.

(11)

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

HAS ADOPTED THIS DECISION:

Article 1

Annex C to Directive 64/432/EEC is replaced by the text in the Annex to this Decision.

Article 2

Article 1 of Decision 2004/226/EC is replaced by the following:

‘Article 1

The complement fixation test, the buffered Brucella antigen test (rose Bengal test (RBT)), the ELISA tests and the fluorescence polarisation assay (FPA) carried out in accordance with Annex C to Directive 64/432/EEC are hereby approved for certification purposes.’

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 10 December 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission


(1)  OJ 121, 29.7.1964, p. 1977/64.

(2)  OJ L 68, 6.3.2004, p. 36.

(3)  http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178620772731.htm


ANNEX

1.

Annex C to Directive 64/432/EEC is replaced by the following:

‘ANNEX C

BRUCELLOSIS

1.   IDENTIFICATION OF THE AGENT

The demonstration by modified acid-fast or immunospecific staining of organisms of Brucella morphology in abortion material, vaginal discharges or milk provides presumptive evidence of brucellosis, especially if supported by serological tests. The polymerase chain reaction (PCR) methods provide additional means of detection.

Whenever possible, Brucella spp. should be isolated using plain or selective media by culture from uterine discharges, aborted foetuses, udder secretions or selected tissues, such as lymph nodes and male and female reproductive organs.

After isolation, the species and biovar shall be identified by phage lysis and/or oxidative metabolism tests, cultural, biochemical and serological criteria. PCR can provide both a complementary and biotyping method based on specific genomic sequences.

The techniques and media used, their standardisation and the interpretation of results must conform to that specified in the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Sixth Edition, 2008, Chapter 2.4.3 (bovine brucellosis), Chapter 2.7.2 (caprine and ovine brucellosis) and Chapter 2.8.5 (porcine brucellosis).

2.   IMMUNOLOGICAL TESTS

2.1.   Standards

2.1.1.   The Brucella abortus biovar 1 Weybridge strain No 99 or USDA strain 1119-3 must be used for the preparation of all antigens used in the rose Bengal test (RBT), serum agglutination test (SAT), complement fixation test (CFT) and the milk ring test (MRT).

2.1.2.   The standard reference serum for the RBT, SAT, CFT and MRT shall be the OIE international reference standard serum (OIEISS) formerly named WHO second international anti-Brucella abortus Serum (ISAbS).

2.1.3.   The standard reference sera for enzyme-linked immunosorbent assays (ELISAs) shall be:

the OIEISS,

the weak positive OIE ELISA standard serum (OIEELISAWPSS),

the strong positive OIE ELISA standard serum (OIEELISASPSS),

the negative OIE ELISA standard serum (OIEELISANSS).

2.1.4.   The standard reference sera for fluorescence polarisation assays (FPAs) shall be:

the weak positive OIE ELISA standard serum (OIEELISAWPSS),

the strong positive OIE ELISA standard serum (OIEELISASPSS),

the negative OIE ELISA standard serum (OIEELISANSS).

2.1.5.   The standard sera listed in 2.1.3 and 2.1.4 are available from the Community reference laboratory for brucellosis or the Veterinary Laboratories Agency (VLA), Weybridge, United Kingdom.

2.1.6.   The OIEISS, the OIEELISAWPSS, the OIEELISASPSS and the OIEELISANSS are international primary standards from which secondary reference national standards serum (working standards) must be established for each test referred to in 2.1.1 in each Member State.

2.2.   Enzyme-linked immunosorbent assays (ELISAs) or other binding assays for the detection of bovine brucellosis in serum or milk

2.2.1.   Material and reagents

The technique used and the interpretation of results must have been validated in accordance with the principles laid down in Chapter 1.1.4 of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Sixth Edition, 2008, and must include at least laboratory and diagnostic studies.

2.2.2.   Standardisation of the test

2.2.2.1.   Standardisation of the test procedure for individual serum samples:

(a)

a 1/150 pre-dilution (1) of the OIEISS or a 1/2 pre-dilution of the OIEELISAWPSS or a 1/16 pre-dilution of the OIEELISASPSS made up in a negative serum (or in a negative pool of sera) must give a positive reaction;

(b)

a 1/600 pre-dilution of the OIEISS or a 1/8 pre-dilution of the OIEELISAWPSS or a 1/64 pre-dilution of the OIEELISASPSS made up in a negative serum (or in a negative pool of sera) must give a negative reaction;

(c)

the OIEELISANSS must always give a negative reaction.

2.2.2.2.   Standardisation of the test procedure for pooled serum samples:

(a)

a 1/150 pre-dilution of the OIEISS or a 1/2 pre-dilution of the OIEELISAWPSS or a 1/16 pre-dilution of the OIEELISASPSS made up in a negative serum (or in a negative pool of sera) and again diluted in negative sera by the number of samples making up the pool must give a positive reaction;

(b)

the OIEELISANSS must always give a negative reaction;

(c)

the test must be adequate to detect evidence of infection in a single animal of the group of animals, of which samples of serum have been pooled.

2.2.2.3.   Standardisation of the test procedure for pooled milk or whey samples:

(a)

a 1/1 000 pre-dilution of the OIEISS or a 1/16 pre-dilution of the OIEELISAWPSS or a 1/125 pre-dilution of the OIEELISASPSS made up in a negative serum (or in a negative pool of sera) and again diluted 1/10 in negative milk must give a positive reaction;

(b)

the OIEELISANSS diluted 1/10 in negative milk must always give a negative reaction;

(c)

the test must be adequate to detect evidence of infection in a single animal of the group of animals, of which samples of milk or whey have been pooled.

2.2.3.   Conditions for use of the ELISAs for diagnosis of bovine brucellosis:

2.2.3.1.   Using the calibrating conditions for ELISAs set out in point 2.2.2.1 and 2.2.2.2 on serum samples, the diagnostic sensitivity of ELISA shall be equal or greater than the RBT or CFT taking into account the epidemiological situation under which it is employed.

2.2.3.2.   Using the calibrating conditions for ELISA set out in point 2.2.2.3 on pooled milk samples, the diagnostic sensitivity of ELISA shall be equal or greater than the MRT taking into account not only the epidemiological situation but also the average and expected extreme husbandry systems.

2.2.3.3.   Where ELISAs are used for certification purposes in accordance with Article 6(1) or for the establishment and maintenance of a herd status in accordance with Annex A(II)(10), pooling of samples of serum must be carried out in such a way that the test results can be undoubtedly related to the individual animal included in the pool. Any confirmatory test must be carried out on samples of serum taken from individual animals.

2.2.3.4.   The ELISAs may be used on a sample of milk taken from the milk collected from a farm with at least 30 % of dairy cows in milk. If that method is used, measures must be taken to ensure that the samples taken for examination can be undoubtedly related to the individual animals from which the milk derived. Any confirmatory test must be carried out on samples of serum taken from individual animals.

2.3.   Complement fixation test (CFT)

2.3.1.   The antigen represents a bacterial suspension in phenol-saline (NaCl 0,85 % (m/v) and phenol at 0,5 % (v/v)) or in a veronal buffer. Antigens may be delivered in the concentrated state provided the dilution factor to be used is indicated on the bottle label. The antigen must be stored at 4 °C and not frozen.

2.3.2.   Serums must be inactivated as follows:

bovine serum: 56 to 60 °C for 30 to 50 minutes,

porcine serum: 60 °C for 30 to 50 minutes.

2.3.3.   In order to carry out the genuine reaction within the test procedure, a complement dose higher than the minimum necessary for total haemolysis shall be used.

2.3.4.   In carrying out the complement fixation test, the following controls must be made each time:

(a)

control of the anti-complementary effect of the serum;

(b)

control of the antigen;

(c)

control of sensitised red blood cells;

(d)

control of the complement;

(e)

control using a positive serum of sensitivity at the start of the reaction;

(f)

control of the specificity of the reaction using a negative serum.

2.3.5.   Calculation of results

The OIEISS contains 1 000 international CFT units (ICFTU) per ml. If the OIEISS is tested in a given method the result is given as a titre (i.e. highest direct dilution of the OIEISS giving 50 % haemolysis, TOIEISS). The test result for the test serum given as titre (TTESTSERUM) must be expressed in ICFTU per ml. In order to convert the expression of a titre into ICFTU, the factor (F) necessary to convert a titre of an unknown test serum (TTESTSERUM) tested by that method into the ICFTU expression can be found from the formula:

F = 1 000 × 1/TOIEISS

and the content of international CFT units per ml of test serum (ICFTUTESTSERUM) from the formula:

ICFTUTESTSERUM = F × TTESTSERUM

2.3.6.   Interpretation of results

A serum containing 20 or more ICFTU per ml shall be considered to be positive.

2.4.   Milk ring test (MRT)

2.4.1.   The antigen represents a bacterial suspension in phenol-saline (NaCl 0,85 % (m/v) and phenol at 0,5 % (v/v)) stained with haematoxylin. The antigen must be stored at 4 °C and not frozen.

2.4.2.   The antigen sensitivity must be standardised in relation to the OIEISS in such a way that the antigen produces a positive reaction with a 1/500 dilution of the OIEISS in negative milk, while a 1/1 000 dilution must be negative.

2.4.3.   The ring test must be made on samples representing the contents of each milk churn or the content of each bulk tank from the farm.

2.4.4.   The milk samples must not have been frozen, heated or subjected to violent shaking.

2.4.5.   The reaction must be carried out using one of the following methods:

on a column of milk of at least 25 mm height and on a volume of milk of 1 ml to which either 0,03 ml or 0,05 ml of one of the standardised stained antigens has been added,

on a column of milk of at least 25 mm height and on a volume of milk of 2 ml to which 0,05 ml of one of the standardised stained antigens has been added,

on a volume of milk of 8 ml to which 0,08 ml of one of the standardised stained antigens has been added.

2.4.6.   The mixture of milk and antigens must be incubated at 37 °C for 60 minutes, together with positive and negative working standards. A subsequent 16- to 24-hours incubation at 4 °C increases the sensitivity of the test.

2.4.7.   Interpretation of results:

(a)

negative reaction: coloured milk, colourless cream;

(b)

positive reaction:

identically coloured milk and cream, or

colourless milk and coloured cream.

2.5.   Buffered Brucella antigen test (Rose Bengal test (RBT))

2.5.1.   The antigen represents a bacterial suspension in buffered Brucella antigen diluent at a pH of 3,65 ± 0,05, stained by the use of rose Bengal dye. The antigen shall be delivered ready for use and must be stored at 4 °C and not frozen.

2.5.2.   The antigen shall be prepared without reference to the cell concentration, but its sensitivity must be standardised in relation to the OIEISS in such a way that the antigen produces a positive reaction with a serum dilution of 1/45 and a negative reaction with a dilution of 1/55.

2.5.3.   The RBT shall be carried out in the following manner:

(a)

serum (20-30 μl) is mixed with an equal volume of antigen on a white tile or enamel plate to produce a zone approximately 2 cm in diameter. The mixture is rocked gently for four minutes at ambient temperature, and then observed in a good light for agglutination;

(b)

an automated method may be used but must be at least as sensitive and accurate as the manual method.

2.5.4.   Interpretation of results

Any visible reaction shall be considered to be positive, unless there has been excessive drying round the edges.

Positive and negative working standards shall be included in each series of tests.

2.6.   Serum agglutination test (SAT)

2.6.1.   The antigen represents a bacterial suspension in phenol-saline (NaCl 0,85 % (m/v) and phenol at 0,5 % (v/v)).

Formaldehyde must not be used.

Antigens may be delivered in the concentrated state provided the dilution factor to be used is indicated on the bottle label.

EDTA may be added to the antigen suspension to 5 mM final test dilution to reduce the level of false positives to the serum agglutination test. Subsequently the pH of 7.2 must be readjusted in the antigen suspension.

2.6.2.   The OIEISS contains 1 000 international units of agglutination.

2.6.3.   The antigen shall be prepared without reference to the cell concentration, but its sensitivity must be standardised in relation to the OIEISS in such a way that the antigen produces either a 50 % agglutination with a final serum dilution of 1/600 to 1/1 000 or 75 % agglutination with a final serum dilution of 1/500 to 1/750.

It may also be advisable to compare the reactivity of new and previously standardised batches of antigen using a panel of defined sera.

2.6.4.   The test shall be performed either in tubes or in microplates. The mixture of antigen and serum dilutions shall be incubated for 16- to 24-hours at 37 °C.

At least three dilutions must be prepared for each serum. Dilutions of suspect serum must be made in such a way that reading of the reaction at the positivity limit is made in the median tube (or well for the microplate method).

2.6.5.   Interpretation of results:

The degree of Brucella agglutination in a serum must be expressed in IU per ml.

A serum containing 30 or more IU per ml is considered to be positive.

2.7.   Fluorescence polarisation assay (FPA)

2.7.1.   The FPA can be performed in glass tubes or a 96-well plate format. The technique used, its standardisation and the interpretation of results must conform to that specified Chapter 2.4.3 (bovine brucellosis) of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Sixth Edition, 2008.

2.7.2.   Standardisation of the test

The FPA shall be standardised so that:

(a)

the OIEELISASPSS and OIEELISAWPSS consistently give positive results.

(b)

a 1/8 pre-dilution of the OIEELISAWPSS or a 1/64 pre-dilution of the OIEELISASPSS made up in a negative serum (or in a negative pool of sera) always gives a negative reaction;

(c)

the OIEELISANSS always gives a negative reaction.

The following shall be included in each batch of tests: a strong positive, a weak positive, a negative working standard serum (calibrated against the OIE ELISA Standard Sera).

3.   COMPLEMENTARY TESTS

3.1.   Brucellosis skin test (BST)

3.1.1.   Conditions for the use of BST

(a)

The brucellosis skin test shall not be used for the purpose of certification for intra-Community trade.

(b)

The brucellosis skin test is one of the most specific tests for the detection of brucellosis in unvaccinated animals; however diagnosis must not be made on the basis of positive intradermal reactions alone.

(c)

Bovine animals, tested with negative result in one of the serological tests defined in this Annex and reacting positively to the BST shall be regarded as infected or suspected to be infected.

(d)

Bovine animals, tested with positive result in one of the serological tests defined in this Annex may be subject to a BST in order to support the interpretation of the serological test results; in particular where in officially brucellosis-free or brucellosis-free bovine herds a cross-reaction with antibodies against other bacteria cannot be excluded.

3.1.2.   The test must be carried out by use of a standardised and defined brucellosis allergen preparation that does not contain smooth lipopolysaccharide (LPS) antigen, as this may provoke non-specific inflammatory reactions or interfere with subsequent serological tests.

The requirements for the production of brucellin shall comply with Section C1 of Chapter 2.4.3 of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Sixth Edition, 2008.

3.1.3.   Test procedure

3.1.3.1.   A volume of 0.1 ml of brucellosis allergen shall be injected intradermally into the caudal fold, the skin of the flank, or the side of the neck.

3.1.3.2.   The test shall be read after 48- to 72-hours.

3.1.3.3.   The skin thickness at the injection site shall be measured with vernier callipers before injection and at re-examination.

3.1.3.4.   Interpretation of results:

 

Strong reactions are easily recognised by local swelling and induration.

 

Skin thickening of 1 to 2 mm shall be considered as positive reaction to the BST.

3.2.   Competitive enzyme-linked immunosorbent assay (cELISA)

3.2.1.   Conditions for the use of cELISA

The cELISA shall not be used for the purpose of certification for intra-Community trade.

Bovine animals, tested with positive result in one of the other serological tests defined in this Annex may be subject to a cELISA in order to support the interpretation of the other serological test results; in particular where in the officially brucellosis-free or brucellosis-free bovine herds a cross-reaction with antibodies against other bacteria cannot be excluded or to eliminate reactions due to residual antibodies produced in response to vaccination with S19.

3.2.2.   Test procedure

The test shall be carried out in accordance with the prescription in Section B(2) of Chapter 2.4.3 of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Sixth Edition, 2008.’

2.

In Annex C to Directive 64/432/EEC point 4.1 is replaced by the following:

‘4.1.   Tasks and responsibilities

National reference laboratories designated in accordance with Article 6a shall be responsible for:

(a)

the approval of the results of the validation studies demonstrating the reliability of the test method used in the Member State;

(b)

determination of the maximum number of samples to be pooled in ELISA kits used;

(c)

calibration of working standards as referred to in point 2.1.6;

(d)

quality checks of all antigens and ELISA kits batches used in the Member State;

(e)

following recommendations of, and cooperating with the Community reference laboratory for brucellosis.’


(1)  For the purpose of this Annex, dilutions given for making up liquid reagents are expressed as, for example, 1/150 shall mean a 1 in 150 dilution.


31.12.2008   

EN

Official Journal of the European Union

L 352/46


COMMISSION DECISION

of 15 December 2008

authorising the placing on the market of leaves of Morinda citrifolia as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council

(notified under document number C(2008) 8108)

(Only the English text is authentic)

(2008/985/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (1), and in particular Article 7 thereof,

Whereas:

(1)

On 10 November 2004 Baker & McKenzie on behalf of Morinda Inc., made a request to the competent authorities of Belgium to place the leaves of Morinda citrifolia on the market as a novel food ingredient.

(2)

On 30 November 2005 the competent food assessment body of Belgium issued its initial assessment report. In that report it came to the conclusion that an additional assessment was required.

(3)

The Commission forwarded the initial assessment report to all Member States on 21 March 2006.

(4)

Some Member States raised additional questions about the safety of the leaves of Morinda citrifolia.

(5)

Therefore the European Food Safety Authority (EFSA) was consulted on 14 November 2006.

(6)

On 10 July 2008 EFSA adopted the ‘Opinion of the Scientific Panel on dietetic Products, Nutrition and Allergies on a request from the Commission related to the safety of leaves from Morinda citrifolia L.’.

(7)

In the opinion the panel came to the conclusion that the use of dried and roasted M. citrifolia leaves for the preparation of infusions at the anticipated levels of intake is safe.

(8)

On the basis of the scientific assessment, it is established that dried and roasted leaves of Morinda citrifolia comply with the criteria laid down in Article 3(1) of Regulation (EC) No 258/97.

(9)

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

HAS ADOPTED THIS DECISION:

Article 1

Dried and roasted leaves of Morinda citrifolia as specified in the Annex may be placed on the market in the Community as a novel food ingredient for the preparation of infusions.

Article 2

The designation of the novel food ingredient authorised by this Decision on the labelling of the foodstuff containing it shall be ‘Noni leaves’ or ‘leaves of Morinda citrifolia’.

Article 3

Dried and roasted leaves of Morinda citrifolia shall be exclusively used for the preparation of infusions. They shall be presented in such a manner that a cup of infusion to be consumed would not be prepared with more than 1 g of dried and roasted leaves of Morinda citrifolia.

Article 4

This Decision is addressed to Morinda Inc., 333 West River Park Drive, Provo, Utah 84604, USA.

Done at Brussels, 15 December 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission


(1)  OJ L 43, 14.2.1997, p. 1.


ANNEX

SPECIFICATIONS OF DRIED AND ROASTED LEAVES OF MORINDA CITRIFOLIA

Description

After cutting, the leaves of Morinda citrifolia are subject to drying and roasting steps. The product has a particle size ranging from broken leaves to coarse powder with fines. It is of greenish brown to brown colour.

Composition of dried and roasted leaves of M. citrifolia

Moisture

< 5,2 %

Protein

17 to 20 %

Carbohydrate

55 to 65 %

Ash

10 to 13 %

Fat

4-9 %

Oxalic acid

< 0,14 %

Tannic acid

< 2,7 %

5,15-dimethylmorindol

less than 47 mg/kg

Rubiadin

non detectable

Lucidin

non detectable


31.12.2008   

EN

Official Journal of the European Union

L 352/48


COMMISSION DECISION

of 15 December 2008

concerning the non-inclusion of antraquinone in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing that substance

(notified under document number C(2008) 8133)

(Text with EEA relevance)

(2008/986/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular the fourth subparagraph of Article 8(2) thereof,

Whereas:

(1)

Article 8(2) of Directive 91/414/EEC provides that a Member State may, during a period of 12 years following the notification of that Directive, authorise the placing on the market of plant protection products containing active substances not listed in Annex I to that Directive that are already on the market two years after the date of notification, while those substances are gradually being examined within the framework of a programme of work.

(2)

Commission Regulations (EC) No 1112/2002 (2) and (EC) No 2229/2004 (3) lay down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes antraquinone.

(3)

For antraquinone the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 1112/2002 and (EC) No 2229/2004 for a range of uses proposed by the notifier. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 20 of Regulation (EC) No 2229/2004. For antraquinone the rapporteur Member State was Belgium and all relevant information was submitted in September 2006.

(4)

The Commission examined antraquinone in accordance with Article 24a of Regulation (EC) No 2229/2004. A draft review report for that substance was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 26 September 2008 in the format of the Commission review report.

(5)

During the examination of this active substance by the Committee, taking into account comments received from Member States, it was concluded that there are clear indications that it may be expected that it has harmful effects on human health and in particular the crucial missing data does not allow to set reliable acceptable daily intake (ADI), acute reference dose (ARfD) and acceptable operator exposure level (AOEL) and such values are necessary to conduct the risk assessment. Moreover, other concerns which were identified by the rapporteur Member State in its assessment report are included in the review report for the substance.

(6)

The Commission invited the notifier to submit its comments on the results of the examination of antraquinone and on its intention or not to further support the substance. The notifier submitted its comments which have been carefully examined. However, despite the arguments put forward by the notifier, the concerns identified could not be eliminated, and assessments made on the basis of the information submitted have not demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing antraquinone satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.

(7)

Antraquinone should therefore not be included in Annex I to Directive 91/414/EEC.

(8)

Measures should be taken to ensure that authorisations granted for plant protection products containing antraquinone are withdrawn within a fixed period of time and are not renewed and that no new authorisations for such products are granted.

(9)

Any period of grace granted by a Member State for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing antraquinone should be limited to 12 months in order to allow existing stocks to be used in one further growing season, which ensures that plant protection products containing antraquinone remain available for 18 months from the adoption of this Decision.

(10)

This Decision does not prejudice the submission of an application for antraquinone in accordance with Article 6(2) of Directive 91/414/EEC and Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (4), in view of a possible inclusion in its Annex I.

(11)

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

HAS ADOPTED THIS DECISION:

Article 1

Antraquinone shall not be included as an active substance in Annex I to Directive 91/414/EEC.

Article 2

Member States shall ensure that:

(a)

authorisations for plant protection products containing antraquinone are withdrawn by 15 June 2009;

(b)

no authorisations for plant protection products containing antraquinone are granted or renewed from the date of publication of this Decision.

Article 3

Any period of grace granted by Member States in accordance with the provisions of Article 4(6) of Directive 91/414/EEC, shall be as short as possible and shall expire on 15 June 2010 at the latest.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 15 December 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission


(1)  OJ L 230, 19.8.1991, p. 1.

(2)  OJ L 168, 27.6.2002, p. 14.

(3)  OJ L 379, 24.12.2004, p. 13.

(4)  OJ L 15, 18.1.2008, p. 5.


31.12.2008   

EN

Official Journal of the European Union

L 352/50


COMMISSION DECISION

of 16 December 2008

on the allocation to Latvia of additional fishing days in the Baltic Sea within subdivisions 25 and 26

(notified under document number C(2008) 8217)

(Only the Latvian text is authentic)

(2008/987/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Regulation (EC) No 1404/2007 of 26 November 2007 fixing the fishing opportunities and associated conditions for certain fish stocks and groups of stocks applicable in the Baltic Sea for 2008 (1), and in particular point 1.3 of Annex II,

Whereas:

(1)

Point 1.1 of Annex II to Regulation (EC) No 1404/2007 specifies the maximum number of days on which a vessel fishing with trawls, Danish seines or similar gear of a mesh size equal to or larger than 90 mm, with gillnets, entangling nets or trammel nets of a mesh size equal to or larger than 90 mm, with bottom set lines, longlines except drifting lines, handlines and jigging equipment may be absent from port in subdivisions 25-27 and 28.2 with the exception of the period from 1 July to 31 August when Article 8 paragraph 1(b) of Council Regulation (EC) No 1098/2007 of 18 September 2007 establishing a multiannual plan for the cod stocks in the Baltic Sea and the fisheries exploiting those stocks, amending Regulation (EEC) No 2847/93 and repealing Regulation (EC) No 779/97 (2) applies.

(2)

In accordance with Article 1 of Commission Regulation (EC) No 169/2008 (3), ICES subdivisions 27 and 28.2 are excluded from the scope of certain fishing effort limitations and recording obligations for 2008, pursuant to Regulation (EC) No 1098/2007.

(3)

Point 1.3 of Annex II to Regulation (EC) No 1404/2007 enables the Commission to allocate an additional number of up to four fishing days absent from port on the basis of permanent cessations of fishing activities that have taken place since 1 January 2005.

(4)

Latvia submitted in January 2008 a request in accordance with point 1.4 of Annex II to Regulation (EC) No 1404/2007, containing, in particular a list of Latvian vessels fishing with above-mentioned gear which have ceased activities since 1 January 2005. Supplementary information was submitted by Latvia on 4 June and 10 July 2008.

(5)

According to the Community TAC and quota database, Latvia has exchanged 661 tonnes out of 694 tonnes of its cod quota in subdivision 22-24. The days absent from port already set for Latvia for fishing in subdivision 22-24 are sufficient for remaining fishing opportunities and there is no need for allocation of additional days to this area.

(6)

In view of the data submitted, four additional days in addition to the already allowed 178 days at sea for vessels fishing with above-mentioned gear can be allocated to Latvia to be used in 2008 in ICES subdivisions 25 and 26.

(7)

The measures provided for in this Decision are in accordance with the opinion of the Committee for Fisheries and Aquaculture,

HAS ADOPTED THIS DECISION:

Article 1

The maximum number of days, as laid down in point 1.1(b) of Annex II to Regulation (EC) No 1404/2007, a Latvian fishing vessel may be absent from port per year in the Baltic Sea subdivisions 25 and 26 shall be increased by four additional days. This Decision applies to vessels using trawls, Danish seines or similar gear of a mesh size equal to or larger than 90 mm, with gillnets, entangling nets or trammel nets of a mesh size equal to or larger than 90 mm, with bottom set lines, longlines except drifting lines, handlines and jigging equipment.

Article 2

This Decision is addressed to the Republic of Latvia.

Done at Brussels, 16 December 2008.

For the Commission

Joe BORG

Member of the Commission


(1)  OJ L 312, 30.11.2007, p. 1.

(2)  OJ L 248, 22.9.2007, p. 1.

(3)  OJ L 51, 26.2.2008, p. 3.


31.12.2008   

EN

Official Journal of the European Union

L 352/52


COMMISSION DECISION

of 17 December 2008

amending Decision 2008/185/EC as regards the inclusion of the Netherlands in the list of Member States free of Aujeszky’s disease and of Hungary in the list of Member States where an approved national control programme for that disease is in place

(notified under document number C(2008) 8325)

(Text with EEA relevance)

(2008/988/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 64/432/EEC of 26 June 1964 on animal health problems affecting intra-Community trade in bovine animals and swine (1), and in particular Articles 9(2) and 10(2) thereof,

Whereas:

(1)

Directive 64/432/EEC lays down rules applicable to intra-Community trade in bovine animals and swine. Article 9 of that Directive provides criteria for approving compulsory national control programmes for certain contagious diseases, including Aujeszky’s disease. In addition, Article 10 of that Directive requires documentation for approving a Member State or region thereof as being free of certain contagious diseases, including Aujeszky’s disease.

(2)

Commission Decision 2008/185/EC of 21 February 2008 on additional guarantees in intra-Community trade of pigs relating to Aujeszky’s disease and criteria to provide information on this disease (2) lays down the additional guarantees for movements of pigs between Member States. Those guarantees are linked to the classification of Member States according to their disease status.

(3)

Annex I to Decision 2008/185/EC lists Member States or regions thereof which are free of Aujeszky’s disease and where vaccination is prohibited. Annex II to that Decision lists Member States or regions thereof where approved control programmes for Aujeszky’s disease are in place.

(4)

The Netherlands and Hungary have submitted supporting documentation to the Commission as regards their Aujeszky’s disease status. In both Member States, national control programmes for Aujeszky’s disease have been implemented for several years.

(5)

The Commission has examined the documentation submitted by those two Member States and found that the Netherlands complies with Article 10(1) of Directive 64/432/EEC. Accordingly, that Member State should be included in the list set out in Annex I to Decision 2008/185/EC.

(6)

The Commission has also found that the national control programme presented by Hungary complies with the criteria laid down in Article 9(1) of Directive 64/432/EEC. Accordingly, Hungary should be included in the list set out in Annex II to Decision 2008/185/EC.

(7)

Decision 2008/185/EC should therefore be amended accordingly.

(8)

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

HAS ADOPTED THIS DECISION:

Article 1

Annexes I and II to Decision 2008/185/EC are replaced by the text in the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 17 December 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission


(1)  OJ 121, 29.7.1964, p. 1977/64.

(2)  OJ L 59, 4.3.2008, p. 19.


ANNEX

ANNEX I

Member States or regions thereof free of Aujeszky’s disease and where vaccination is prohibited

ISO code

Member State

Regions

AT

Austria

All regions

CY

Cyprus

All regions

CZ

Czech Republic

All regions

DE

Germany

All regions

DK

Denmark

All regions

FI

Finland

All regions

FR

France

The departments of Ain, Aisne, Allier, Alpes-de-Haute-Provence, Alpes-Maritimes, Ardèche, Ardennes, Ariège, Aube, Aude, Aveyron, Bas-Rhin, Bouches-du-Rhône, Calvados, Cantal, Charente, Charente-Maritime, Cher, Corrèze, Côte-d’Or, Côtes-d’Armor, Creuse, Deux-Sèvres, Dordogne, Doubs, Drôme, Essonne, Eure, Eure-et-Loir, Finistère, Gard, Gers, Gironde, Hautes-Alpes, Hauts-de-Seine, Haute Garonne, Haute-Loire, Haute-Marne, Hautes-Pyrénées, Haut-Rhin, Haute-Saône, Haute-Savoie, Haute-Vienne, Hérault, Ille-et-Vilaine, Indre, Indre-et-Loire, Isère, Jura, Landes, Loire, Loire-Atlantique, Loir-et-Cher, Loiret, Lot, Lot-et-Garonne, Lozère, Maine-et-Loire, Manche, Marne, Mayenne, Meurthe-et-Moselle, Meuse, Morbihan, Moselle, Nièvre, Nord, Oise, Orne, Paris, Pas-de-Calais, Pyrénées-Atlantiques, Pyrénées-Orientales, Puy-de-Dôme, Réunion, Rhône, Sarthe, Saône-et-Loire, Savoie, Seine-et-Marne, Seine-Maritime, Seine-Saint-Denis, Somme, Tarn, Tarn-et-Garonne, Territoire de Belfort, Val-de-Marne, Val-d’Oise, Var, Vaucluse, Vendée, Vienne, Vosges, Yonne, Yvelines

LU

Luxembourg

All regions

NL

The Netherlands

All regions

SK

Slovakia

All regions

SE

Sweden

All regions

UK

United Kingdom

All regions in England, Scotland and Wales

ANNEX II

Member States or regions thereof where approved Aujeszky’s disease control programmes are in place

ISO code

Member State

Regions

BE

Belgium

All regions

ES

Spain

The territory of the Autonomous Communities of Galicia, País Vasco, Asturias, Cantabria, Navarra, La Rioja

The territory of the provinces of León, Zamora, Palencia, Burgos, Valladolid and Ávila in the Autonomous Community of Castilla y León

The territory of the province of Las Palmas in the Canary Islands

HU

Hungary

All regions

IT

Italy

The province of Bolzano


31.12.2008   

EN

Official Journal of the European Union

L 352/55


COMMISSION DECISION

of 23 December 2008

authorising Member States, in accordance with Council Directive 1999/105/EC, to take decisions on the equivalence of the guarantees afforded by forest reproductive material to be imported from certain third countries

(notified under document number C(2008) 8589)

(2008/989/EC)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to the Council Directive 1999/105/EC of 22 December 1999 on the marketing of forest reproductive material (1), and in particular Article 19(3) thereof,

Whereas:

(1)

In accordance with Article 19(1) of Directive 1999/105/EC, a Council Decision is being adopted on the equivalence of forest reproductive material produced in third countries setting out the conditions under which forest reproductive material of the categories ‘source identified’ and ‘selected’ produced in certain third countries may be imported into the Community. However, for certain other third countries the information presently available at Community level is not sufficient to include those third countries in that Decision. This is the case of Belarus, Bosnia and Herzegovina, The former Yugoslav Republic of Macedonia and New Zealand.

(2)

In order to prevent trade patterns from being disrupted upon the expiry of Commission Decision 2005/942/EC of 21 December 2005 authorising Member States to take decisions under Council Directive 1999/105/EC on assurances afforded in respect of forest reproductive material produced in third countries (2), Member States should be authorised to take decisions on whether certain material imported from those third countries offers equivalent guarantees to those applicable to forest reproductive material produced in the Community in accordance with Directive 1999/105/EC.

(3)

In order to permit a future possible extension of the Council Decision on the equivalence for forest reproductive material produced in third countries, to third countries other than those listed by the above Decision, a sufficient time period necessary for the implementation of the OECD International Scheme for Certification of Forest Reproductive Material Moving in International Trade by those third countries is requested. Therefore, it should be appropriate to extend the period of the validity of this Decision to 31 December 2014. The period of application of this Decision should be sufficiently long to allow any risk of a disruption of imports into Member States to be avoided.

(4)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,

HAS ADOPTED THIS DECISION:

Article 1

Member States are authorised to decide in respect of the third countries listed in the Annex, and in respect of the species, categories and types of basic material set out therein whether forest reproductive material produced in those countries affords the equivalent guarantees as regards the approval of its basic material and the measures taken for its production with a view to marketing as does forest reproductive material produced within the Community and complying with the provisions of Directive 1999/105/EC.

The forest reproductive material listed in the Annex shall be accompanied by a master certificate or an official certificate issued by the country of origin and records which shall contain details of all consignments to be exported, to be provided by the supplier in the third country.

Article 2

Member States shall immediately notify the Commission and other Member States of any decisions taken pursuant to this Decision, and of any withdrawal of such decisions.

Article 3

This Decision shall apply from 1 January 2009 to 31 December 2014.

Article 4

This Decision is addressed to the Member States.

Done at Brussels, 23 December 2008.

For the Commission

Androulla VASSILIOU

Member of the Commission


(1)  OJ L 11, 15.1.2000, p. 17.

(2)  OJ L 342, 24.12.2005, p. 92.


ANNEX

Country of origin

Species

Category

Type of basic material

Belarus

Picea abies Karst.

SI

SS, St

Bosnia and Herzegovina

Pinus nigra Arnold

SI

SS, St

The former Yugoslav Republic of Macedonia

Abies alba Mill.

SI

SS, St

New Zealand

Pinus radiata D. Don

SI

SS, St

Category

SI

Source Identified

Type of basic material

SS

Seed Source

St

Stand


European Central Bank

31.12.2008   

EN

Official Journal of the European Union

L 352/58


DECISION OF THE EUROPEAN CENTRAL BANK

of 11 December 2008

on the approval of the volume of coin issuance in 2009

(ECB/2008/20)

(2008/990/EC)

THE GOVERNING COUNCIL OF THE EUROPEAN CENTRAL BANK,

Having regard to the Treaty establishing the European Community, and in particular Article 106(2) thereof,

Having regard to Council Decision 2008/608/EC of 8 July 2008 in accordance with Article 122(2) of the Treaty on the adoption by Slovakia of the single currency on 1 January 2009 (1), and in particular Article 1 thereof,

Whereas:

(1)

The European Central Bank (ECB) has the exclusive right from 1 January 1999 to approve the volume of coins issued by the Member States that have adopted the euro (hereinafter the ‘participating Member States’).

(2)

The derogation in favour of Slovakia referred to in Article 4 of the 2003 Act of Accession has been abrogated with effect from 1 January 2009.

(3)

The 15 current participating Member States and Slovakia have submitted to the ECB for approval their estimates of the volume of euro coins to be issued in 2009, supplemented by explanatory notes on the forecasting methodology,

HAS ADOPTED THIS DECISION:

Article 1

Approval of the volume of euro coins to be issued in 2009

The ECB hereby approves the volume of euro coins to be issued by the participating Member States in 2009 as described in the following table:

(EUR million)

 

Issuance of coins intended for circulation and issuance of collector coins (not intended for circulation) in 2009

Belgium

105,4

Germany

632,0

Ireland

65,5

Greece

85,7

Spain

390,0

France

252,5

Italy

234,3

Cyprus

22,5

Luxembourg

42,0

Malta

15,4

Netherlands

68,5

Austria

216,0

Portugal

50,0

Slovenia

27,0

Slovakia

131,0

Finland

60,0

Article 2

Final provision

This Decision is addressed to the participating Member States.

Done at Frankfurt am Main, 11 December 2008.

The President of the ECB

Jean-Claude TRICHET


(1)  OJ L 195, 24.7.2008, p. 24.


ACP-CE Council of Ministers

31.12.2008   

EN

Official Journal of the European Union

L 352/59


DECISION No 3/2008 OF THE ACP-EC COUNCIL OF MINISTERS

of 15 December 2008

to adopt amendments to Annex IV to the Partnership Agreement

(2008/991/EC)

THE ACP-EC COUNCIL OF MINISTERS,

Having regard to the Partnership Agreement between the members of the African, Caribbean and Pacific Group of States (‘the ACP States’), of the one part, and the European Community and its Member States, of the other part, signed in Cotonou (Benin) on 23 June 2000 and revised in Luxembourg on 25 June 2005 (‘the ACP-EC Partnership Agreement’) (1), and in particular Articles 15.3, 81 and 100 thereof,

Having regard to the recommendation of the ACP-EC Development Finance Cooperation Committee,

Whereas:

(1)

In order to improve efficiency and to promote harmonisation, a series of provisions were incorporated into Annex IV to the ACP-EC Partnership Agreement regarding management procedures and implementation. However, the provisions of Annex IV concerning the awarding and performance of contracts remained under discussion.

(2)

The signature of the revised ACP-EC Partnership Agreement on 25 June 2005 was accompanied by Declaration No VIII, under the title ‘Joint Declaration on Article 19a of Annex IV’, which states ‘In accordance with Article 100 of the Cotonou Agreement, the Council of Ministers will examine the provisions of Annex IV concerning the awarding and performance of contracts with a view to adopting them before the Agreement amending the Cotonou Agreement enters into force’.

(3)

The text for the new Article 19c replacing Articles 21, 23, 25, 27, 28 and 29 of Annex IV fulfils the objectives of simplification, clarification and harmonisation of procurement and management procedures governing contracts which are funded by the European Community.

(4)

It is therefore appropriate to amend Annex IV to the ACP-EC Partnership Agreement accordingly,

HAS DECIDED AS FOLLOWS:

Article 1

Annex IV to the ACP-EC Partnership Agreement is hereby amended as follows:

1.

Articles 21, 23, 25, 27, 28 and 29 shall be deleted;

2.

the following Article shall be inserted:

‘Article 19c

Awarding contracts, awarding grants and performing contracts

1.   Except as provided for in Article 26, contracts and grants shall be attributed and implemented according to Community rules and, except in the specific cases provided for by these rules, according to the standard procedures and documentation set and published by the Commission for the purposes of implementing cooperation actions with third countries and in force at the time the procedure in question is launched.

2.   In decentralised management, where a joint assessment shows that the procedures for awarding contracts and grants in the ACP State or the recipient region or the procedures approved by the fund providers are in accordance with the principles of transparency, proportionality, equal treatment and non-discrimination and preclude any kind of conflict of interest, the Commission shall use these procedures, in accordance with the Paris Declaration and without prejudice to Article 26, in full respect of the rules governing the exercise of its powers in this field.

3.   The ACP State or recipient region shall undertake to check regularly that the operations financed by the Fund have been properly implemented, to take appropriate measures to prevent irregularities and fraud, and, if necessary, to take legal action to recover unduly paid funds.

4.   In decentralised management, contracts are negotiated, established, signed and performed by the ACP States. These States may, however, call upon the Commission to negotiate, establish, sign and perform contracts on their behalf.

5.   Pursuant to the commitment referred to in Article 50 of this Agreement, contracts and grants financed from Fund resources shall be performed in accordance with internationally recognised basic standards in the field of labour law.

6.   An expert group of representatives of the Secretariat of the ACP Group of States and the Commission shall be set up to identify, at the request of one or other of the parties, any appropriate alterations and to suggest amendments and improvements to the rules and procedures referred to in paragraphs 1 and 2.

This group shall also submit a periodic report to the ACP-EC Development Finance Cooperation Committee to assist it in its task of examining the problems surrounding the implementation of development cooperation activities and proposing appropriate measures.’

Article 2

The procedure for adoption of the present Decision within the ACP-EC Council of Ministers shall be a written procedure.

Done at Brussels, 15 December 2008.

The Chairman

of the ACP-EC Committee of Ambassadors by delegation, for the ACP-EC Council of Ministers

P. SELLAL


(1)  OJ L 287, 28.10.2005, p. 4.


31.12.2008   

EN

Official Journal of the European Union

L 352/61


Information on the date of entry into force of the decision modifying Annex IV to the ACP-EC Partnership Agreement

Decision No 3/2008 of the ACP-EC Council of Ministers of 15 December 2008 to adopt amendments to Annex IV to the Partnership Agreement entered into force on 15 December 2008 following a written procedure between the two parties (1).


(1)  See page 59 of this Official Journal.


31.12.2008   

EN

Official Journal of the European Union

L 352/62


The European Community and Antigua and Barbuda, Bahamas, Barbados, Belize, Dominica, the Dominican Republic, Grenada, Guyana, Jamaica, Saint Christopher and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Suriname, Trinidad and Tobago have notified the completion of the procedures necessary for provisional application of the Economic Partnership Agreement between the CARIFORUM States, of the one part, and the European Community and its Member States, of the other part (1), in accordance with Article 243 of that Agreement. Consequently the Agreement will apply provisionally as from 29 December 2008. On this date, pursuant to Article 4 of Council Regulation (EC) No 1528/2007, Protocol I of the Agreement concerning the definition of the concept of ‘originating products’ will supersede the provisions contained in Annex II to such Regulation. On the same date, pursuant to Article 5.5 of Council Regulation (EC) No 1528/2007 the temporary suspension procedures set out in paragraphs 2 to 4 of Article 5 shall be superseded by those contained in Article 20 of the Agreement.


(1)  OJ L 289, 30.10.2008, p. 3.


Corrigenda

31.12.2008   

EN

Official Journal of the European Union

L 352/63


Corrigendum to Decision 2007/792/EC of the Representatives of the Governments of the Member States meeting within the Council of 26 November 2007 amending Decision 2005/446/EC setting the deadline for the commitment of the funds of the Ninth European Development Fund (EDF)

( Official Journal of the European Union L 320 of 6 December 2007 )

The corrigendum published on page 40 of Official Journal L 43 of 19 February 2008 is cancelled and replaced by the following text:

on page 32, Sole Article (concerning Article 2(1) of Decision 2005/446/EC):

for:

‘1.   The date beyond which the interest rate subsidies managed by the European Investment Bank (EIB) to provide resources of the Investment Facility on concessional terms will not be committed, shall be set at 31 December 2007 or the date of entry into force of the Tenth EDF, whichever is the later. This date could be reviewed if need be.’,

read:

‘1.   The date beyond which the interest rate subsidies managed by the European Investment Bank (EIB) will not be committed, shall be set at 31 December 2007 or the date of entry into force of the Tenth EDF, whichever is the later. This date could be reviewed if need be.’.


31.12.2008   

EN

Official Journal of the European Union

L 352/s3


NOTE TO THE READER

The institutions have decided no longer to quote in their texts the last amendment to cited acts.

Unless otherwise indicated, references to acts in the texts published here are to the version of those acts currently in force.