ISSN 1977-0677

Official Journal

of the European Union

L 247

European flag  

English edition

Legislation

Volume 59
15 September 2016


Contents

 

II   Non-legislative acts

page

 

 

REGULATIONS

 

*

Commission Delegated Regulation (EU) 2016/1649 of 8 July 2016 supplementing Regulation (EU) No 1316/2013 of the European Parliament and of the Council establishing the Connecting Europe Facility ( 1 )

1

 

*

Commission Regulation (EU) 2016/1650 of 9 September 2016 establishing a prohibition of fishing for redfish in NAFO 3M area by vessels flying the flag of a Member State of the European Union

5

 

*

Commission Regulation (EU) 2016/1651 of 9 September 2016 establishing a prohibition of fishing for undulate ray in Union waters of VIIe by vessels flying the flag of France

7

 

*

Commission Regulation (EU) 2016/1652 of 9 September 2016 establishing a prohibition of fishing for whiting in area VIII by vessels flying the flag of Belgium

9

 

 

Commission Implementing Regulation (EU) 2016/1653 of 14 September 2016 establishing the standard import values for determining the entry price of certain fruit and vegetables

11

 

 

DECISIONS

 

*

Decision (EU, Euratom) 2016/1654 of the Representatives of the Governments of the Member States of 7 September 2016 appointing Judges to the General Court

13

 

*

Decision (EU, Euratom) 2016/1655 of the Representatives of the Governments of the Member States of 7 September 2016 appointing Judges to the General Court

15

 

*

Decision (EU, Euratom) 2016/1656 of the Representatives of the Governments of the Member States of 7 September 2016 appointing an Advocate-General to the Court of Justice

17

 

*

Decision (EU, Euratom) 2016/1657 of the representatives of the Governments of the Member States of 7 September 2016 appointing a Judge to the General Court

18

 

*

Commission Implementing Decision (EU) 2016/1658 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5747)  ( 1 )

19

 

*

Commission Implementing Decision (EU) 2016/1659 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5748)  ( 1 )

22

 

 

III   Other acts

 

 

EUROPEAN ECONOMIC AREA

 

*

Decision of the Standing Committee of the EFTA States No 1/2016/SC of 28 April 2016 on internal cost sharing [2016/1660]

27

 


 

(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.


II Non-legislative acts

REGULATIONS

15.9.2016   

EN

Official Journal of the European Union

L 247/1


COMMISSION DELEGATED REGULATION (EU) 2016/1649

of 8 July 2016

supplementing Regulation (EU) No 1316/2013 of the European Parliament and of the Council establishing the Connecting Europe Facility

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1316/2013 of the European Parliament and of the Council of 11 December 2013 establishing the Connecting Europe Facility, amending Regulation (EU) No 913/2010 and repealing Regulations (EC) No 680/2007 and (EC) No 67/2010 (1), and in particular Article 21 thereof,

Whereas:

(1)

On 7 January 2014 the Commission adopted Delegated Regulation (EU) No 275/2014 (2) establishing transport funding priorities for the purpose of the multiannual and annual work programmes.

(2)

By its judgement of 17 March 2016 in Case C-286/14 European Parliament v Commission the Court of Justice of the European Union annulled Delegated Regulation (EU) No 275/2014 and ordered that the effects of that Regulation be maintained until the entry into force, within a reasonable period, which may not exceed six months from the date of delivery of the judgment, of a new act intended to replace it.

(3)

According to Article 21(3) of Regulation (EU) No 1316/2013, the transport funding priorities should take into account the eligible actions contributing to projects of common interest in accordance with Regulation (EU) No 1315/2013 of the European Parliament and of the Council (3) listed under Article 7(2) of Regulation (EU) No 1316/2013.

(4)

The eligible actions listed in Article 7(2) of Regulation (EU) No 1316/2013 are further detailed in Articles 10 and 11 of that Regulation providing the maximum applicable funding rates for those actions. It is therefore appropriate to refer to the actions as listed in those Articles in order to detail the transport funding priorities.

(5)

Projects of common interest as listed in Part I of Annex I to Regulation (EU) No 1316/2013 are eligible to the multiannual work programmes referred to in Article 17(3) of that Regulation. Projects not listed in Part I of Annex I but eligible as per Article 7(2) of that Regulation are eligible to the annual work programmes.

(6)

Pursuant to Article 4(2) of Regulation (EU) No 1316/2013 laying down the specific transport sectoral objectives, and considering that Article 21(3) of that Regulation empowers the Commission to adopt delegated acts in accordance with its Article 26 detailing, for the transport sector, the funding priorities to be reflected in the work programmes, this Delegated Regulation sets out such priorities to be reflected in multi-annual or annual work programmes in accordance with Article 17(3) of the said Regulation.

(7)

Considering that financial instruments are to receive Union contribution under the annual work programmes, it is appropriate to include hereby a corresponding priority.

(8)

Programmes support actions listed in Article 5(2)(b) of Regulation (EU) No 1316/2013, consisting of technical and administrative assistance expenses incurred by the Commission for the management of the Connecting Europe Facility and capped at 1 % of the financial envelope, will not be covered by the work programmes. However the programme support actions contributing to projects of common interest as provided for in Article 7(2) and referred to in Article 5(2)(a) of Regulation (EU) No 1316/2013 will be covered by the work programmes and are included hereby with a corresponding priority.

(9)

All resources referred in Article 5(1)(a) of Regulation (EU) No 1316/2013, including the resources transferred from the Cohesion Fund will be covered under the same work programmes. According to Article 11 of that Regulation, the resources transferred from the Cohesion Fund will be subject to specific calls for proposals.

(10)

In order to allow for the timely adoption of the implementing acts provided for in Article 17(3) of Regulation (EU) No 1316/2013 to ensure legal continuity of the Connecting Europe Facility — Transport sector — programme, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union,

HAS ADOPTED THIS REGULATION:

Article 1

This Regulation establishes the funding priorities to be reflected in the multiannual and annual work programmes referred to in Article 17 of Regulation (EU) No 1316/2013 for the duration of the Connecting Europe Facility for eligible actions under Article 7(2) of that Regulation, as set out in the Annex.

Article 2

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

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

Done at Brussels, 8 July 2016.

For the Commission

The President

Jean-Claude JUNCKER


(1)   OJ L 348, 20.12.2013, p. 129.

(2)  Commission Delegated Regulation (EU) No 275/2014 of 7 January 2014 amending Annex I to Regulation (EU) No 1316/2013 of the European Parliament and of the Council establishing the Connecting Europe Facility (OJ L 80, 19.3.2014, p. 1).

(3)  Regulation (EU) No 1315/2013 of the European Parliament and of the Council of 11 December 2013 on Union guidelines for the development of the trans-European transport network and repealing Decision No 661/2010/EU (OJ L 348, 20.12.2013, p. 1).


ANNEX

TRANSPORT FUNDING PRIORITIES FOR THE PURPOSE OF THE MULTIANNUAL AND ANNUAL WORK PROGRAMMES

1.   Funding priorities for the multiannual work programmes

1.1.   Funding priorities for the objective of bridging missing links, removing bottlenecks, enhancing rail interoperability, and, in particular, improving cross-border sections:

(i)

pre-identified projects on the Corridors of the Core Network (railways, inland waterways, roads, maritime and inland ports).

(ii)

pre-identified projects on the other sections of the Core Network (railways, inland waterways, roads, maritime and inland ports).

(iii)

rail interoperability.

(iv)

deployment of ERTMS.

1.2.   Funding priorities for the objective of ensuring sustainable and efficient transport systems in the long run, with a view to preparing for expected future transport flows, as well as enabling all modes of transport to be decarbonised through transition to innovative low-carbon and energy-efficient transport technologies, while optimising safety:

(i)

deployment of new technologies and innovation in all transport modes, with a focus on decarbonisation, safety and innovative technologies for the promotion of sustainability, operation, management, accessibility, multimodality and efficiency of the network;

(ii)

safe and secure infrastructure, including safe and secure parking on the road Core Network.

1.3.   Funding priorities for the objective of optimising the integration and interconnection of transport modes and enhancing the interoperability of transport services, while ensuring the accessibility of transport infrastructures:

(i)

single European sky — SESAR;

(ii)

river information services;

(iii)

intelligent transport services for road;

(iv)

vessel traffic monitoring and information systems;

(v)

motorways of the sea;

(vi)

actions implementing transport infrastructure in nodes of the Core Network, including urban nodes;

(vii)

connections to and development of multimodal logistics platforms.

1.4.   Programme support actions

2.   Funding priorities for the annual work programmes

2.1.   Funding priorities for the objective of removing bottlenecks, enhancing rail interoperability, bridging missing links and, in particular, improving cross-border sections:

(i)

railways, inland waterways and roads projects on the Core Network including connections to inland and maritime ports and airports, as well as development of ports;

(ii)

projects on the Comprehensive Network (railways, inland waterways, roads, maritime and inland ports);

(iii)

projects to connect the trans-European transport network with infrastructure networks of the neighbouring countries, in particular related to cross-border sections (railways, inland waterways, roads, maritime and inland ports).

2.2.   Funding priorities for the objective of ensuring sustainable and efficient transport systems in the long run, with a view to preparing for expected future transport flows, as well as enabling all modes of transport to be decarbonised through transition to innovative low-carbon and energy-efficient transport technologies, while optimising safety:

(i)

Deployment of new technologies and innovation, other than those covered by the multiannual work programme;

(ii)

freight transport services;

(iii)

actions to reduce rail freight noise, including by retrofitting of existing rolling stock.

2.3.   Funding priorities for the objective of optimising the integration and interconnection of transport modes and enhancing the interoperability of transport services, while ensuring the accessibility of transport infrastructures:

(i)

telematic applications systems other than those covered by the multiannual work programme;

(ii)

actions for better accessibility to transport infrastructure for disabled persons;

(iii)

actions implementing transport infrastructure in nodes of the Core Network, including urban nodes;

(iv)

connections to and development of multimodal logistics platforms.

2.4.   CEF financial instruments:

(i)

contribution to the financial instruments, as defined in Article 14 and Part III of the CEF annex;

(ii)

programme support actions for innovative financial instruments.


15.9.2016   

EN

Official Journal of the European Union

L 247/5


COMMISSION REGULATION (EU) 2016/1650

of 9 September 2016

establishing a prohibition of fishing for redfish in NAFO 3M area by vessels flying the flag of a Member State of the European Union

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (1), and in particular Article 36(2) thereof,

Whereas:

(1)

Council Regulation (EU) 2016/72 (2) lays down quotas for 2016.

(2)

According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2016.

(3)

It is therefore necessary to prohibit fishing activities for that stock,

HAS ADOPTED THIS REGULATION:

Article 1

Quota exhaustion

The fishing quota allocated to the Member State referred to in the Annex to this Regulation for the stock referred to therein for 2016 shall be deemed to be exhausted from the date set out in that Annex.

Article 2

Prohibitions

Fishing activities for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein shall be prohibited from the date set out in that Annex. In particular it shall be prohibited to retain on board, relocate, tranship or land fish from that stock caught by those vessels after that date.

Article 3

Entry into force

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

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

Done at Brussels, 9 September 2016.

For the Commission,

On behalf of the President,

João AGUIAR MACHADO

Director-General for Maritime Affairs and Fisheries


(1)   OJ L 343, 22.12.2009, p. 1.

(2)  Council Regulation (EU) 2016/72 of 22 January 2016 fixing for 2016 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters, and amending Regulation (EU) 2015/104 (OJ L 22, 28.1.2016, p. 1).


ANNEX

No

18/TQ72

Member State

European Union (All Member States)

Stock

RED/N3M.

Species

Redfish (Sebastes spp)

Zone

NAFO 3M

Closing date

10.7.2016 at 12.00 UTC


15.9.2016   

EN

Official Journal of the European Union

L 247/7


COMMISSION REGULATION (EU) 2016/1651

of 9 September 2016

establishing a prohibition of fishing for undulate ray in Union waters of VIIe by vessels flying the flag of France

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (1), and in particular Article 36(2) thereof,

Whereas:

(1)

Council Regulation (EU) 2016/72 (2), lays down quotas for 2016.

(2)

According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2016.

(3)

It is therefore necessary to prohibit fishing activities for that stock,

HAS ADOPTED THIS REGULATION:

Article 1

Quota exhaustion

The fishing quota allocated to the Member State referred to in the Annex to this Regulation for the stock referred to therein for 2016 shall be deemed to be exhausted from the date set out in that Annex.

Article 2

Prohibitions

Fishing activities for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein shall be prohibited from the date set out in that Annex. In particular it shall be prohibited to retain on board, relocate, tranship or land fish from that stock caught by those vessels after that date.

Article 3

Entry into force

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

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

Done at Brussels, 9 September 2016.

For the Commission,

On behalf of the President,

João AGUIAR MACHADO

Director-General for Maritime Affairs and Fisheries


(1)   OJ L 343, 22.12.2009, p. 1.

(2)  Council Regulation (EU) 2016/72 of 22 January 2016 fixing for 2016 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters, and amending Regulation (EU) 2015/104 (OJ L 22, 28.1.2016, p. 1).


ANNEX

No

19/TQ72

Member State

France

Stock

RJU/67AKXD

Species

Undulate ray (Raja undulata)

Zone

Union waters of VIIe

Closing date

11.7.2016


15.9.2016   

EN

Official Journal of the European Union

L 247/9


COMMISSION REGULATION (EU) 2016/1652

of 9 September 2016

establishing a prohibition of fishing for whiting in area VIII by vessels flying the flag of Belgium

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Community control system for ensuring compliance with the rules of the common fisheries policy (1), and in particular Article 36(2) thereof,

Whereas:

(1)

Council Regulation (EU) 2016/72 (2) lays down quotas for 2016.

(2)

According to the information received by the Commission, catches of the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein have exhausted the quota allocated for 2016.

(3)

It is therefore necessary to prohibit fishing activities for that stock,

HAS ADOPTED THIS REGULATION:

Article 1

Quota exhaustion

The fishing quota allocated to the Member State referred to in the Annex to this Regulation for the stock referred to therein for 2016 shall be deemed to be exhausted from the date set out in that Annex.

Article 2

Prohibitions

Fishing activities for the stock referred to in the Annex to this Regulation by vessels flying the flag of or registered in the Member State referred to therein shall be prohibited from the date set out in that Annex. In particular it shall be prohibited to retain on board, relocate, tranship or land fish from that stock caught by those vessels after that date.

Article 3

Entry into force

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

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

Done at Brussels, 9 September 2016.

For the Commission,

On behalf of the President,

João AGUIAR MACHADO

Director-General for Maritime Affairs and Fisheries


(1)   OJ L 343, 22.12.2009, p. 1.

(2)  Council Regulation (EU) 2016/72 of 22 January 2016 fixing for 2016 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters, and amending Regulation (EU) 2015/104 (OJ L 22, 28.1.2016, p. 1).


ANNEX

No

23/TQ72

Member State

Belgium

Stock

WHG/08.

Species

Whiting (Merlangius merlangus)

Zone

VIII

Closing date

20.8.2016


15.9.2016   

EN

Official Journal of the European Union

L 247/11


COMMISSION IMPLEMENTING REGULATION (EU) 2016/1653

of 14 September 2016

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

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),

Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,

Whereas:

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

HAS ADOPTED THIS REGULATION:

Article 1

The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.

Article 2

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

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

Done at Brussels, 14 September 2016.

For the Commission,

On behalf of the President,

Jerzy PLEWA

Director-General for Agriculture and Rural Development


(1)   OJ L 347, 20.12.2013, p. 671.

(2)   OJ L 157, 15.6.2011, p. 1.


ANNEX

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

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

MA

167,1

ZZ

167,1

0707 00 05

TR

121,6

ZZ

121,6

0709 93 10

TR

133,0

ZZ

133,0

0805 50 10

AR

121,3

CL

143,0

TR

147,3

UY

130,7

ZA

139,2

ZZ

136,3

0806 10 10

TR

134,7

ZZ

134,7

0808 10 80

AR

166,6

BR

97,9

CL

126,5

NZ

121,9

US

141,5

ZA

105,6

ZZ

126,7

0808 30 90

AR

168,5

CL

206,1

TR

137,4

ZA

113,8

ZZ

156,5

0809 30 10 , 0809 30 90

TR

136,4

ZZ

136,4


(1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7). Code ‘ZZ’ stands for ‘of other origin’.


DECISIONS

15.9.2016   

EN

Official Journal of the European Union

L 247/13


DECISION (EU, Euratom) 2016/1654 OF THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES

of 7 September 2016

appointing Judges to the General Court

THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 19 thereof,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 254 and 255 thereof,

Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 106a(1) thereof,

Whereas:

(1)

Article 48 of Protocol No 3 on the Statute of the Court of Justice of the European Union, as amended by Regulation (EU, Euratom) 2015/2422 of the European Parliament and of the Council (1), provides that the General Court consists of 40 Judges as from 25 December 2015. Point (a) of Article 2 of that Regulation determines the term of office of the 12 additional Judges such that the end of their respective terms of office coincides with to the partial replacements of the membership of the General Court which will take place on 1 September 2016 and 1 September 2019.

(2)

It is on that basis that Mr Jan PASSER has been nominated for the post of additional Judge of the General Court.

(3)

Furthermore, Article 48 of Protocol No 3 on the Statute of the Court of Justice of the European Union, as amended by Regulation (EU, Euratom) 2015/2422, provides that the General Court consists of 47 Judges as from 1 September 2016. Point (b) of Article 2 of that Regulation determines the term of office of the seven additional Judges such that the end of their respective terms of office coincides with the partial replacements of the membership of the General Court which will take place on 1 September 2019 and 1 September 2022.

(4)

It is on that basis that Mr René BARENTS, Ms Maria José COSTEIRA, Mr Alexander KORNEZOV, Mr Ezio PERILLO and Mr Jesper SVENNINGSEN have been nominated for the posts of additional Judges at the General Court.

(5)

The panel set up by Article 255 of the Treaty on the Functioning of the European Union has given an opinion on the suitability of Mr René BARENTS, Ms Maria José COSTEIRA, Mr Alexander KORNEZOV, Mr Jan PASSER, Mr Ezio PERILLO and Mr Jesper SVENNINGSEN to perform the duties of Judges of the General Court.

(6)

It is appropriate to appoint Mr Jan PASSER for the period from the date of entry into force of this Decision to 31 August 2019. It is also appropriate to appoint Ms Maria José COSTEIRA for the period from the date of entry into force of this Decision to 31 August 2022.

(7)

Given that Mr René BARENTS, Mr Alexander KORNEZOV, Mr Ezio PERILLO and Mr Jesper SVENNINGSEN performed the duties of Judges of the Civil Service Tribunal until the dissolution of that Tribunal on 31 August 2016, and given that jurisdiction at first instance in disputes between the Union and its servants is transferred to the General Court from 1 September 2016 by Regulation (EU, Euratom) 2016/1192 of the European Parliament and of the Council (2), it is appropriate to appoint Mr Alexander KORNEZOV and Mr Ezio PERILLO for a term of office commencing on 1 September 2016 and ending on 31 August 2019, and to appoint Mr René BARENTS and Mr Jesper SVENNINGSEN for a term of office commencing on 1 September 2016 and ending on 31 August 2022,

HAVE ADOPTED THIS DECISION:

Article 1

Mr Jan PASSER is hereby appointed a Judge of the General Court for the period from the date of entry into force of this Decision to 31 August 2019.

Article 2

Ms Maria José COSTEIRA is hereby appointed a Judge of the General Court for the period from the date of entry into force of this Decision to 31 August 2022.

Article 3

The following persons are hereby appointed Judges of the General Court for the period from 1 September 2016 to 31 August 2019:

Mr Alexander KORNEZOV,

Mr Ezio PERILLO.

Article 4

The following persons are hereby appointed Judges of the General Court for the period from 1 September 2016 to 31 August 2022:

Mr René BARENTS,

Mr Jesper SVENNINGSEN.

Article 5

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

Done at Brussels, 7 September 2016.

The President

P. JAVORČÍK


(1)  Regulation (EU, Euratom) 2015/2422 of the European Parliament and of the Council of 16 December 2015 amending Protocol No 3 on the Statute of the Court of Justice of the European Union (OJ L 341, 24.12.2015, p. 14).

(2)  Regulation (EU, Euratom) 2016/1192 of the European Parliament and of the Council of 6 July 2016 on the transfer to the General Court of jurisdiction at first instance in disputes between the European Union and its servants (OJ L 200, 26.7.2016, p. 137).


15.9.2016   

EN

Official Journal of the European Union

L 247/15


DECISION (EU, Euratom) 2016/1655 OF THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES

of 7 September 2016

appointing Judges to the General Court

THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 19 thereof,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 254 and 255 thereof,

Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 106a(1) thereof,

Whereas:

(1)

The terms of office of 14 Judges of the General Court are due to expire on 31 August 2016. In addition, the terms of office of the Judges referred to in Article 1 of Decision (EU, Euratom) 2016/484 of the Representatives of the Governments of the Member States (1), are also due to expire on 31 August 2016, as laid down in that Article.

(2)

Mr Barna BERKE, Mr Ricardo da SILVA PASSOS and Ms Octavia SPINEANU-MATEI have been nominated as for the posts of Judges of the General Court.

(3)

Furthermore, it is proposed that the terms of office of Mr Zoltán CSEHI, Mr Constantinos ILIOPOULOS, Ms Anna MARCOULLI and Mr Dean SPIELMANN be renewed.

(4)

The panel set up by Article 255 of the Treaty on the Functioning of the European Union has given an opinion on the suitability of Mr Barna BERKE, Mr Zoltán CSEHI, Mr Constantinos ILIOPOULOS, Ms Anna MARCOULLI, Mr Ricardo da SILVA PASSOS, Mr Dean SPIELMANN and Ms Octavia SPINEANU-MATEI, to perform the duties of Judges of the General Court.

(5)

It is appropriate to appoint Mr Barna BERKE, Mr Ricardo da SILVA PASSOS and Ms Octavia SPINEANU-MATEI for the period from the date of entry into force of this Decision to 31 August 2022.

(6)

It is appropriate to appoint Mr Zoltán CSEHI, Mr Constantinos ILIOPOULOS, Ms Anna MARCOULLI and Mr Dean SPIELMANN for a further term of office starting on 1 September 2016 and ending on 31 August 2022. Given that those four Judges are already Judges of the General Court until 31 August 2016 and have continued to hold office pending the adoption of this Decision, it is appropriate to appoint them for a new term of office with effect from the day after the end of their previous term of office,

HAVE ADOPTED THIS DECISION:

Article 1

The following persons are hereby appointed Judges of the General Court for the period from the date of entry into force of this Decision to 31 August 2022:

Mr Barna BERKE,

Mr Ricardo da SILVA PASSOS,

Ms Octavia SPINEANU-MATEI.

Article 2

The following persons are hereby appointed Judges of the General Court for the period from 1 September 2016 to 31 August 2022:

Mr Zoltán CSEHI,

Mr Constantinos ILIOPOULOS,

Ms Anna MARCOULLI,

Mr Dean SPIELMANN.

Article 3

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

Done at Brussels, 7 September 2016.

The President

P. JAVORČÍK


(1)  Decision (EU, Euratom) 2016/484 of the Representatives of the Governments of the Member States of 23 March 2016 appointing Judges to the General Court (OJ L 87, 2.4.2016, p. 31).


15.9.2016   

EN

Official Journal of the European Union

L 247/17


DECISION (EU, Euratom) 2016/1656 OF THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES

of 7 September 2016

appointing an Advocate-General to the Court of Justice

THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 19 thereof,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 253 and 255 thereof,

Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 106a(1) thereof,

Whereas:

(1)

The terms of office of 14 Judges and four Advocates-General of the Court of Justice expired on 6 October 2015. In addition, Council Decision 2013/336/EU (1) increased the number of Advocates-General of the Court of Justice to 11, with effect from 7 October 2015.

(2)

It is on that basis that Mr Evgeni TANCHEV was nominated for the post of Advocate-General of the Court of Justice.

(3)

The panel set up by Article 255 of the Treaty on the Functioning of the European Union has given an opinion on the suitability of Mr Evgeni TANCHEV to perform the duties of Advocate-General of the Court of Justice.

(4)

Mr Evgeni TANCHEV should therefore be appointed for the period from the date of entry into force of this Decision to 6 October 2021,

HAVE ADOPTED THIS DECISION:

Article 1

Mr Evgeni TANCHEV is hereby appointed an Advocate-General of the Court of Justice for the period from the date of entry into force of this Decision to 6 October 2021.

Article 2

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

Done at Brussels, 7 September 2016.

The President

P. JAVORČÍK


(1)  Council Decision 2013/336/EU of 25 June 2013 increasing the number of Advocates-General of the Court of Justice of the European Union (OJ L 179, 29.6.2013, p. 92).


15.9.2016   

EN

Official Journal of the European Union

L 247/18


DECISION (EU, Euratom) 2016/1657 OF THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES

of 7 September 2016

appointing a Judge to the General Court

THE REPRESENTATIVES OF THE GOVERNMENTS OF THE MEMBER STATES OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 19 thereof,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 254 and 255 thereof,

Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Article 106a(1) thereof,

Whereas:

(1)

Under Articles 5 and 7 of Protocol No 3 on the Statute of the Court of Justice of the European Union, and following the resignation of Mr Carl WETTER as of 19 September 2016, a Judge should be appointed to the General Court for the remainder of the term of office of Mr WETTER, which runs until 31 August 2019.

(2)

Mr Ulf ÖBERG has been proposed for the vacant post.

(3)

The panel set up under Article 255 of the Treaty on the Functioning of the European Union has given an opinion on the suitability of Mr ÖBERG to perform the duties of Judge of the General Court,

HAVE ADOPTED THIS DECISION:

Article 1

Mr Ulf ÖBERG is hereby appointed a Judge of the General Court for the period from 19 September 2016 to 31 August 2019.

Article 2

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

Done at Brussels, 7 September 2016.

The President

P. JAVORČÍK


15.9.2016   

EN

Official Journal of the European Union

L 247/19


COMMISSION IMPLEMENTING DECISION (EU) 2016/1658

of 13 September 2016

amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products

(notified under document C(2016) 5747)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (1), and in particular Article 16f thereof,

Having regard to the opinion of the European Medicines Agency, formulated on 25 March 2014 by the Committee for Herbal Medicinal Products,

Whereas:

(1)

In 2008 an opinion of the European Medicines Agency established that Eleutherococcus senticosus (Rupr. et Maxim) Maxim complied with the requirements set out in Directive 2001/83/EC as a herbal substance, a herbal preparation or a combination thereof within the meaning of that Directive and it was therefore included in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/EC (2).

(2)

As part of its review of monographs and list entries to keep them relevant, the Committee for Herbal Medicinal Products has reviewed the list entry Eleutherococcus senticosus (Rupr. et Maxim) Maxim and adopted an opinion to change the list entry with regard to the name of the herbal substance in certain EU official languages, the phrasing of the herbal preparations, update of the reference to the European Pharmacopoeia and update of some information necessary for the safe use, e.g. revision of the contraindications. Some of those changes are the result of an update of the template for list entries.

(3)

Decision 2008/911/EC should therefore be amended accordingly.

(4)

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

HAS ADOPTED THIS DECISION:

Article 1

Annex II to Decision 2008/911/EC is amended in accordance with the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 13 September 2016.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission


(1)   OJ L 311, 28.11.2001, p. 67.

(2)  Commission Decision 2008/911/EC of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (OJ L 328, 6.12.2008, p. 42).


ANNEX

In Annex II to Decision 2008/911/EC, the entry Eleutherococcus Senticosus (Rupr. et Maxim) Maxim., Radix is amended as follows:

(1)

The section ‘Common name in all EU official languages of herbal substance’ is amended as follows:

(a)

After ‘FR (français): racine d'éleuthérocoque (racine de ginseng sibérien)’ the following is inserted:

‘HR (hrvatska): Korijen sibirskog ginsenga’

(b)

‘Všehojovcový koreň’ related to SK (slovenčina) is replaced by ‘Koreň eleuterokoka’;

(2)

The section ‘Herbal preparation(s)’ is amended as follows:

(a)

‘Comminuted herbal substance for preparation of herbal tea’ is replaced by ‘Comminuted herbal substance’;

(b)

‘Liquid extract (1:1, ethanol 30-40 % v/v)’ is replaced by ‘Liquid extract (DER 1:1, extraction solvent ethanol 30-40 % v/v)’;

(c)

‘Dry extract (13-25: 1, ethanol 28-40 % v/v)’ is replaced by ‘Dry extract (DER 13-25:1, extraction solvent ethanol 28-40 % v/v)’;

(d)

‘Dry aqueous extract (15-17:1)’ is replaced by ‘Dry aqueous extract (DER 15-17:1)’;

(e)

‘Tincture (1:5, ethanol 40 % v/v)’ is replaced by ‘Tincture (ratio of herbal substance to extraction solvent 1:5, extraction solvent ethanol 40 % v/v)’;

(3)

In the section ‘European Pharmacopoeia monograph reference’‘6.0’ is replaced by ‘7.0’;

(4)

In the section ‘Type of tradition’‘Chinese, European.’ is replaced by ‘European, Chinese.’;

(5)

In the section ‘Specified strength’‘Not applicable.’ is replaced by ‘Please see “Specified posology”.’;

(6)

The section ‘Specified posology’ is amended as follows:

(a)

‘over 12 years of age’ is deleted;

(b)

‘Daily dose.’ is replaced by ‘Average daily dose.’;

(c)

‘The use is not recommended in children under 12 years of age’ is replaced by ‘The use in children under 12 years of age is not recommended’;

(7)

The section ‘Any other information necessary for the safe use’ is amended as follows:

(a)

‘Contra-indications’ is replaced by ‘Contraindication’;

(b)

The words ‘Arterial hypertension.’ are deleted;

(c)

The sentence ‘The use in children under 12 years of age is not recommended because sufficient experience is not available’ are replaced by ‘The use in children under 12 years of age is not recommended due to lack of adequate data’;

(d)

After ‘If the symptoms worsen during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.’ the sentence ‘For tinctures and extracts containing ethanol the appropriate labelling for ethanol, taken from the Guideline on excipients in the label and package leaflet of medicinal products for human use, must be included.’ is inserted;

(e)

The title of subsection ‘Pregnancy and lactation’ is replaced by ‘Fertility, pregnancy and lactation’;

After the sentence ‘In the absence of sufficient data, the use during pregnancy and lactation is not recommended.’ ‘No fertility data available.’ is inserted;

(f)

In subsection ‘Undesirable effects’ after ‘The frequency is not known.’ The sentence ‘If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.’ is inserted;

(g)

After subsection ‘Overdose’ the following subsections are inserted:

‘Pharmaceutical particulars (if necessary)

Not applicable.

Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)

Not applicable.’


15.9.2016   

EN

Official Journal of the European Union

L 247/22


COMMISSION IMPLEMENTING DECISION (EU) 2016/1659

of 13 September 2016

amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products

(notified under document C(2016) 5748)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (1), and in particular Article 16f thereof,

Having regard to the opinion of the European Medicines Agency, formulated on 24 November 2014 by the Committee for Herbal Medicinal Products,

Whereas:

(1)

Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum can be considered as a herbal substance, a herbal preparation or a combination thereof within the meaning of Directive 2001/83/EC and it complies with the requirements set out in that Directive.

(2)

It is therefore appropriate to include Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and other species of Melaleuca, aetheroleum in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/EC (2).

(3)

Decision 2008/911/EC should therefore be amended accordingly.

(4)

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

HAS ADOPTED THIS DECISION:

Article 1

Annexes I and II to Decision 2008/911/EC are amended in accordance with the Annex to this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 13 September 2016.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission


(1)   OJ L 311, 28.11.2001, p. 67.

(2)  Commission Decision 2008/911/EC of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (OJ L 328, 6.12.2008, p. 42).


ANNEX

Decision 2008/911/EC is amended as follows:

(1)

In Annex I, the following substance is inserted after Hamamelis virginiana L.:

Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum’;

(2)

In Annex II, the following is inserted after the entry Hamamelis virginiana L.:

‘UNION LIST ENTRY ON MELALEUCA ALTERNIFOLIA (MAIDEN AND BETCH) CHEEL, M. LINARIIFOLIA SMITH, M. DISSITIFLORA F. MUELLER AND/OR OTHER SPECIES OF MELALEUCA, AETHEROLEUM

Scientific name of the plant

Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and other species of Melaleuca

Botanical family

Myrtaceae

Common name in all EU official languages of herbal preparation

BG (bălgarski): Чаено дърво, масло

CS (čeština): silice kajeputu střídavolistého

DA (dansk): Tetræolie

DE (Deutsch): Teebaumöl

EL (elliniká): Μελαλεύκης αιθέριο έλαιο

EN (English): Tea tree oil

ES (español): Melaleuca alternifolia, aceite esencial de

ET (eesti keel): teepuuõli

FI (suomi): teepuuöljy

FR (français): Mélaleuca (arbre à thé) (huile essentielle de)

HR (hrvatska): eteričnog ulje australijskog čajevca

HU (magyar): Teafa-olaj

IT (italiano): Melaleuca essenza

LT (lietuvių kalba): Arbatmedžių eterinis aliejus

LV (latviešu valoda): Tējaskoka ēteriskā eļļa

MT (Malti): Żejt tal-Melaleucae

NL (Nederlands): Theeboomolie

PL (polski): Olejek eteryczny drzewa herbacianego

PT (português): Óleo esencial de melaleuca

RO (română): Melaleuca (arbore de ceai) (ulei esențial)

SK (slovenčina): Silica melaleuky

SL (slovenščina): eterično olje melalevke

SV (svenska): Teträdsolja

NO (norsk): Tetreolje

Herbal preparation

Essential oil

European Pharmacopoeia monograph reference

01/2008:1837

Indications

Indication (a)

Traditional herbal medicinal product for treatment of small superficial wounds and insect bites.

Indication (b)

Traditional herbal medicinal product for treatment of small boils (furuncles and mild acne).

Indication (c)

Traditional herbal medicinal product for the relief of itching and irritation in cases of mild athlete's foot.

Indication (d)

Traditional herbal medicinal product for symptomatic treatment of minor inflammation of the oral mucosa.

The product is a traditional herbal medicinal product for use in specified indication exclusively based upon long-standing use.

Type of tradition

European.

Specified strength

Please see ‘Specified posology’.

Specified posology

Indication (a)

Adolescents, adults and elderly

Single dose

0,03-0,07 ml of undiluted essential oil to be applied to the affected area using a cotton bud 1-3 times daily.

Liquid preparations containing 0,5 % to 10 % of essential oil to be applied to the affected area 1-3 times daily.

Indication (b)

Adolescents, adults and elderly

Single dose

Oily liquid or semi-solid preparations containing 10 % of essential oil to be applied to the affected area 1-3 times daily, or

0,7-1 ml of essential oil stirred into 100 ml of lukewarm water to be applied as an impregnated dressing to the affected areas of skin. Undiluted essential oil to be applied to the boil using a cotton bud 2-3 times daily.

Indication (c)

Adolescents, adults and elderly

Single dose

Oily liquid or semi-solid preparations containing 10 % of essential oil to be applied on the affected area 1-3 times daily. 0,17-0,33 ml of essential oil in an appropriate volume of warm water to cover the feet. Soak feet for 5-10 minutes daily.

Undiluted essential oil to be applied to the affected area using a cotton bud 2-3 times daily.

Indication (d)

Adolescents, adults and elderly

0,17-0,33 ml of essential oil to be mixed in 100 ml of water for rinse or gargle several times daily.

The use in children under 12 years of age is not recommended (see section ‘Special warnings and precautions for use’).

Route of administration

Indications (a), (b) and (c)

Cutaneous use

Indication (d)

Oromucosal use.

Duration of use or any restrictions on the duration of use

Indication (a)

If the symptoms persist longer than 1 week during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Indications (b) and (c)

Not to be used for more than 1 month.

If the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Indication (d)

If the symptoms persist longer than 5 days during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Any other information necessary for the safe use

Contraindications

Hypersensitivity to the active substance or to colophony.

Special warnings and precautions for use

The use in children under 12 years of age has not been established due to lack of adequate data.

If a rash develops, discontinue use.

Not to be used orally or as inhalation.

Not to be used in eyes or ears.

If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.

Indication (a)

If fever or signs of exacerbating skin infection are observed, a doctor or a qualified health care practitioner should be consulted.

Indication (b)

In cases of severe acne a doctor or a qualified health care practitioner shall be consulted.

Indication (c)

For the eradication of fungal infection a doctor or a qualified health care practitioner shall be consulted.

Indication (d)

Not to be swallowed.

Interactions with other medicinal products and other forms of interaction

None reported.

Fertility, pregnancy and lactation

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

No fertility data available.

Effects on ability to drive and use machines

No studies on the effect on the ability to drive and use machines have been performed.

Undesirable effects

Adverse skin reactions including smarting pain, mild pruritus, burning sensation, irritation, itching, stinging, erythema, oedema (contact dermatitis) or other allergic reactions have been reported. The frequency is not known.

Burn-like skin reactions have been reported. The frequency is rare (< 1/1 000).

If other adverse reactions not mentioned occur, a doctor or a qualified health care practitioner should be consulted.

Overdose

Cutaneous use:

None reported.

Oromucosal use:

 

Accidental overdose may cause central nervous system depression and muscle weakness. However, in adults these symptoms generally resolve within 36 hours.

 

If ingestion occurs, the patient should be monitored and standard supportive treatment applied as required.

 

In children, ingestion of tea tree oil is a medical emergency requiring immediate hospital treatment and respiratory support.

Pharmaceutical particulars (if necessary)

Store in air-tight containers, protected from light and heat.

Proper storage and handling are needed to avoid the formation of oxidation products which have greater potential for skin sensitisation.

Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)

Not applicable.’


III Other acts

EUROPEAN ECONOMIC AREA

15.9.2016   

EN

Official Journal of the European Union

L 247/27


DECISION OF THE STANDING COMMITTEE OF THE EFTA STATES

No 1/2016/SC

of 28 April 2016

on internal cost sharing [2016/1660]

THE STANDING COMMITTEE OF THE EFTA STATES

HAS DECIDED AS FOLLOWS:

Article 1

The contributions of Iceland, Liechtenstein and Norway (hereinafter referred to as the EFTA States) to the EEA Financial Mechanism for the period 2014–2021 are to be divided into seven annual tranches and determined on the basis of Article 2.

Article 2

1.   The contributions of the EFTA States to the EEA Financial Mechanism for the period 2014–2021 are based on their Gross Domestic Products (GDP).

2.   For any EFTA State, the contribution for a specific financial year t is to be based on the available GDP data for the year t – 2 and correspond to that States' share of GDP (t – 2) in the overall GDP (t – 2) of the EFTA States.

3.   The respective GDP data on which the contributions for a specific year t are to be based shall be delivered annually by each EFTA States by 1 March. They shall relate to the year t – 2.

4.   Contributions shall be expressed in Euros.

Article 3

The accession of an EFTA State to the EU shall not affect its obligation to contribute to the EEA Financial Mechanism for the period 2014–2021 in accordance with this Decision.

Article 4

This Decision shall take effect on the day of entering into force or on the day of provisional application of the legal act establishing the EEA Financial Mechanism for the period 2014–2021.

Article 5

This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.

Done at Brussels, 28 April 2016.

For the Standing Committee

The Chair

Kurt JÄGER

The Secretary-General

Kristinn F. ÁRNASON


ANNEX

The Standing Committee agrees that, before finalising possible negotiations regarding post 2021 financial contributions to reduce the economic and social disparities in the EEA, a review of the cost sharing mechanism in view of a change from GDP to GNI as the basis for the calculation shall take place.