ISSN 1725-2555

doi:10.3000/17252555.L_2010.012.eng

Official Journal

of the European Union

L 12

European flag  

English edition

Legislation

Volume 53
19 January 2010


Contents

 

II   Non-legislative acts

page

 

 

REGULATIONS

 

*

Commission Regulation (EU) No 41/2010 of 18 January 2010 correcting the French, Latvian and Polish versions of Regulation (EC) No 546/2003 on certain notifications regarding the application of Council Regulations (EEC) No 2771/75, (EEC) No 2777/75 and (EEC) No 2783/75 in the eggs and poultrymeat sectors

1

 

*

Commission Regulation (EU) No 42/2010 of 15 January 2010 concerning the classification of certain goods in the Combined Nomenclature

2

 

 

Commission Regulation (EU) No 43/2010 of 18 January 2010 establishing the standard import values for determining the entry price of certain fruit and vegetables

4

 

 

Commission Regulation (EU) No 44/2010 of 18 January 2010 on the issuing of import licences for applications lodged during the first seven days of January 2010 under tariff quotas opened by Regulation (EC) No 616/2007 for poultrymeat

6

 

 

Commission Regulation (EU) No 45/2010 of 18 January 2010 amending Regulation (EU) No 39/2010 fixing the import duties in the cereals sector applicable from 16 January 2010

8

 

 

DECISIONS

 

 

2010/29/EU

 

*

Council Decision of 18 January 2010 appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2010 to 25 January 2015

11

 

 

2010/30/EU

 

*

Commission Decision of 9 December 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2009) 9703)  ( 1 )

14

 


 

(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

19.1.2010   

EN

Official Journal of the European Union

L 12/1


COMMISSION REGULATION (EU) No 41/2010

of 18 January 2010

correcting the French, Latvian and Polish versions of Regulation (EC) No 546/2003 on certain notifications regarding the application of Council Regulations (EEC) No 2771/75, (EEC) No 2777/75 and (EEC) No 2783/75 in the eggs and poultrymeat sectors

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 192, in conjunction with Article 4 thereof,

Having regard to Regulation (EEC) No 2783/75 of the Council of 29 October 1975 on the common system of trade for ovalbumin and lactalbumin (2), and in particular Article 10 thereof,

Whereas:

(1)

On 15 June 2009, the Commission adopted Regulation (EC) No 504/2009 (3) amending Regulation (EC) No 546/2003 (4). In the French, Latvian and Polish language versions of that Regulation, the term ‘barn’ was translated incorrectly and therefore a correction of those three language versions is necessary. The other language versions are not affected.

(2)

Regulation (EC) No 546/2003 as amended by Regulation (EC) No 504/2009 should therefore be corrected accordingly.

(3)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for the Common Organisation of the Agricultural Markets,

HAS ADOPTED THIS REGULATION:

Article 1

This correcting regulation concerns only the French, the Latvian and the Polish language versions.

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, 18 January 2010.

For the Commission

José Manuel BARROSO

The President


(1)  OJ L 299, 16.11.2007, p. 1.

(2)  OJ L 282, 1.11.1975, p. 104.

(3)  OJ L 151, 16.6.2009, p. 22.

(4)  OJ L 81, 28.3.2003, p. 12.


19.1.2010   

EN

Official Journal of the European Union

L 12/2


COMMISSION REGULATION (EU) No 42/2010

of 15 January 2010

concerning the classification of certain goods in the Combined Nomenclature

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (1), and in particular Article 9(1)(a) thereof,

Whereas:

(1)

In order to ensure uniform application of the Combined Nomenclature annexed to Regulation (EEC) No 2658/87, it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

(2)

Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

(3)

Pursuant to those general rules, the goods described in column 1 of the table set out in the Annex should be classified under the CN code indicated in column 2, by virtue of the reasons set out in column 3 of that table.

(4)

It is appropriate to provide that binding tariff information which has been issued by the customs authorities of Member States in respect of the classification of goods in the Combined Nomenclature but which is not in accordance with this Regulation can, for a period of three months, continue to be invoked by the holder, under Article 12(6) of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (2).

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

HAS ADOPTED THIS REGULATION:

Article 1

The goods described in column 1 of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN code indicated in column 2 of that table.

Article 2

Binding tariff information issued by the customs authorities of Member States, which is not in accordance with this Regulation, can continue to be invoked for a period of three months under Article 12(6) of Regulation (EEC) No 2913/92.

Article 3

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

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

Done at Brussels, 15 January 2010.

For the Commission,

On behalf of the President,

László KOVÁCS

Member of the Commission


(1)  OJ L 256, 7.9.1987, p. 1.

(2)  OJ L 302, 19.10.1992, p. 1.


ANNEX

Description of goods

Classification (CN code)

Reasons

(1)

(2)

(3)

Product consisting of (% by weight):

barley grass, powdered

28,8

honey

27,5

wheatgrass, powdered

21,5

alfalfa, powdered

21,5

stearic acid

0,4

pepper

0,25

chromium picolinate

0,01

(corresponds to 8,7 μg Cr per tablet)

The product is presented for retail sale, in tablet form and used as a food supplement (one tablet twice a day).

2106 90 98

Classification is determined by General Rules 1 and 6 for the interpretation of the Combined Nomenclature and the wording of CN codes 2106, 2106 90 and 2106 90 98.

The product does not meet the requirements of Note 2(b)(2) to Chapter 19 because of its composition, presentation and use as a food supplement.

The product does not meet the requirements of Additional Note 1 to Chapter 30 as no statements on the use for specific diseases or the concentration of active substances are given. It should therefore not be considered as herbal medicinal preparation within the meaning of heading 3004.

The product is therefore considered to be covered by the terms of heading 2106 as a food preparation not elsewhere specified or included and is used as dietary supplement indicated to maintain general health or well-being. (See also HSEN to heading 2106, second paragraph, number 16).


19.1.2010   

EN

Official Journal of the European Union

L 12/4


COMMISSION REGULATION (EU) No 43/2010

of 18 January 2010

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

THE EUROPEAN COMMISSION,

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

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

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

Whereas:

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

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

This Regulation shall enter into force on 19 January 2010.

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

Done at Brussels, 18 January 2010.

For the Commission, On behalf of the President,

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development


(1)  OJ L 299, 16.11.2007, p. 1.

(2)  OJ L 350, 31.12.2007, 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

IL

122,3

JO

64,0

MA

56,4

TN

112,1

TR

115,2

ZZ

94,0

0707 00 05

EG

174,9

JO

101,4

MA

76,9

TR

113,4

ZZ

116,7

0709 90 70

MA

152,8

TR

127,2

ZZ

140,0

0709 90 80

EG

225,1

ZZ

225,1

0805 10 20

EG

52,6

IL

58,0

MA

51,8

TN

68,2

TR

55,8

ZZ

57,3

0805 20 10

MA

85,1

ZZ

85,1

0805 20 30, 0805 20 50, 0805 20 70, 0805 20 90

CN

52,8

EG

67,7

HR

59,0

IL

70,1

JM

120,8

TR

64,3

ZZ

72,5

0805 50 10

EG

64,8

IL

88,6

TR

74,7

US

87,7

ZZ

79,0

0808 10 80

CA

75,3

CL

60,1

CN

91,3

MK

24,7

US

126,9

ZZ

75,7

0808 20 50

CN

66,3

US

101,4

ZZ

83,9


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


19.1.2010   

EN

Official Journal of the European Union

L 12/6


COMMISSION REGULATION (EU) No 44/2010

of 18 January 2010

on the issuing of import licences for applications lodged during the first seven days of January 2010 under tariff quotas opened by Regulation (EC) No 616/2007 for poultrymeat

THE EUROPEAN COMMISSION,

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

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

Having regard to Commission Regulation (EC) No 1301/2006 of 31 August 2006 laying down common rules for the administration of import tariff quotas for agricultural products managed by a system of import licences (2), and in particular Article 7(2) thereof,

Having regard to Commission Regulation (EC) No 616/2007 of 4 June 2007 opening and providing for the administration of Community tariff quotas in the sector of poultrymeat originating in Brazil, Thailand and other third countries (3), and in particular Article 5(5) thereof,

Whereas:

(1)

Regulation (EC) No 616/2007 opened tariff quotas for imports of products in the poultrymeat sector.

(2)

The applications for import licences lodged during the first seven days of January 2010 for the subperiod 1 April to 30 June 2010 relate, for some quotas, to quantities exceeding those available. The extent to which licences may be issued should therefore be determined and an allocation coefficient laid down to be applied to the quantities applied for,

HAS ADOPTED THIS REGULATION:

Article 1

The quantities for which import licence applications have been lodged pursuant to Regulation (EC) No 616/2007 for the subperiod 1 April to 30 June 2010 shall be multiplied by the allocation coefficients set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on 19 January 2010.

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

Done at Brussels, 18 January 2010.

For the Commission,

On behalf of the President,

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development


(1)  OJ L 299, 16.11.2007, p. 1.

(2)  OJ L 238, 1.9.2006, p. 13.

(3)  OJ L 142, 5.6.2007, p. 3.


ANNEX

Group No

Order No

Allocation coefficient for import licence applications lodged for the subperiod from 1.4.2010-30.6.2010

(%)

1

09.4211

0,432311

5

09.4215

12,484317


19.1.2010   

EN

Official Journal of the European Union

L 12/8


COMMISSION REGULATION (EU) No 45/2010

of 18 January 2010

amending Regulation (EU) No 39/2010 fixing the import duties in the cereals sector applicable from 16 January 2010

THE EUROPEAN COMMISSION,

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

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

Having regard to Commission Regulation (EC) No 1249/96 of 28 June 1996 laying down detailed rules for the application of Council Regulation (EEC) No 1766/92 in respect of import duties in the cereals sector (2), and in particular Article 2(1) thereof,

Whereas:

(1)

The import duties in the cereals sector applicable from 16 January 2010 were fixed by Commission Regulation (EU) No 39/2010 (3).

(2)

As the average of the import duties calculated differs by more than EUR 5/tonne from that fixed, a corresponding adjustment must be made to the import duties fixed by Regulation (EU) No 39/2010.

(3)

Regulation (EU) No 39/2010 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes I and II to Regulation (EU) No 39/2010 are hereby replaced by the text 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.

It shall apply from 19 January 2010.

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

Done at Brussels, 18 January 2010.

For the Commission, On behalf of the President,

Jean-Luc DEMARTY

Director-General for Agriculture and Rural Development


(1)  OJ L 299, 16.11.2007, p. 1.

(2)  OJ L 161, 29.6.1996, p. 125.

(3)  OJ L 11, 16.1.2010, p. 3.


ANNEX I

Import duties on the products referred to in Article 136(1) of Regulation (EC) No 1234/2007 applicable from 19 January 2010

CN code

Description

Import duties (1)

(EUR/t)

1001 10 00

Durum wheat, high quality

0,00

medium quality

0,00

low quality

0,00

1001 90 91

Common wheat seed

0,00

ex 1001 90 99

High quality common wheat, other than for sowing

0,00

1002 00 00

Rye

36,92

1005 10 90

Maize seed other than hybrid

18,54

1005 90 00

Maize, other than seed (2)

18,54

1007 00 90

Grain sorghum other than hybrids for sowing

36,92


(1)  For goods arriving in the Community via the Atlantic Ocean or via the Suez Canal the importer may benefit, under Article 2(4) of Regulation (EC) No 1249/96, from a reduction in the duty of:

3 EUR/t, where the port of unloading is on the Mediterranean Sea, or

2 EUR/t, where the port of unloading is in Denmark, Estonia, Ireland, Latvia, Lithuania, Poland, Finland, Sweden, the United Kingdom or the Atlantic coast of the Iberian peninsula.

(2)  The importer may benefit from a flatrate reduction of EUR 24 per tonne where the conditions laid down in Article 2(5) of Regulation (EC) No 1249/96 are met.


ANNEX II

Factors for calculating the duties laid down in Annex I

15.1.2010

1.

Averages over the reference period referred to in Article 2(2) of Regulation (EC) No 1249/96:

(EUR/t)

 

Common wheat (1)

Maize

Durum wheat, high quality

Durum wheat, medium quality (2)

Durum wheat, low quality (3)

Barley

Exchange

Minnéapolis

Chicago

Quotation

155,97

101,75

Fob price USA

165,85

155,85

135,85

98,98

Gulf of Mexico premium

41,51

15,40

Great Lakes premium

2.

Averages over the reference period referred to in Article 2(2) of Regulation (EC) No 1249/96:

Freight costs: Gulf of Mexico–Rotterdam:

23,48 EUR/t

Freight costs: Great Lakes–Rotterdam:

— EUR/t


(1)  Premium of 14 EUR/t incorporated (Article 4(3) of Regulation (EC) No 1249/96).

(2)  Discount of 10 EUR/t (Article 4(3) of Regulation (EC) No 1249/96).

(3)  Discount of 30 EUR/t (Article 4(3) of Regulation (EC) No 1249/96).


DECISIONS

19.1.2010   

EN XM XM

Official Journal of the European Union

L 12/11


COUNCIL DECISION

of 18 January 2010

appointing the members and alternate members of the Committee of the Regions for the period from 26 January 2010 to 25 January 2015

(2010/29/EU)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 300(3) and 305 thereof, in conjunction with Article 8 of the Protocol on Transitional Provisions annexed to the Treaty on European Union and the Treaty on the Functioning of the European Union,

Having regard to the proposals made by each Member State,

Whereas:

(1)

Article 300(3) of the Treaty on the Functioning of the European Union requires that members or alternate members of the Committee of the Regions, besides being representatives of regional or local bodies, ‘either hold a regional or local authority electoral mandate or are politically accountable to an elected assembly’.

(2)

Article 305 of the Treaty on the Functioning of the European Union provides for the members of the Committee and an equal number of alternate members to be appointed by the Council for five years in accordance with the proposals made by each Member State.

(3)

Article 8 of the Protocol on Transitional Provisions sets out the allocation of members of the Committee of the Regions.

(4)

As the term of office of the members and alternate members of the Committee of the Regions is due to expire on 25 January 2010, new members and alternate members should be appointed to the Committee of the Regions.

(5)

On 22 December 2009, the Council adopted the proposals of members and alternate members submitted by the Belgian, Bulgarian, Czech, Danish, Estonian, Greek, Spanish, French, Italian, Cypriot, Latvian, Lithuanian, Luxembourg, Hungarian, Maltese, Dutch, Austrian, Polish, Portuguese, Romanian, Slovenian, Slovak, Finnish, Swedish and British Governments and the list containing 24 members and 23 alternate members submitted by the German Government (1).

(6)

The members and alternate members proposed by the Irish government as well as one alternate member proposed by the German government, should now be appointed to the Committee of the Regions,

HAS ADOPTED THIS DECISION:

Article 1

The following are hereby appointed to the Committee of the Regions for the period from 26 January 2010 to 25 January 2015:

as members, the persons listed by Member State in Annex I,

as alternate members, the persons listed by Member State in Annex II.

Article 2

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

It shall enter into force on the date of its adoption.

Done at Brussels, 18 January 2010.

For the Council

The President

E. ESPINOSA


(1)  OJ L 348, 29.12.2009, p. 22.


ПРИЛОЖЕНИЕ I - ANEXO I - PŘÍLOHA I - BILAG I - ANHANG I - I LISA - ΠΑΡΑΡΤΗΜΑ Ι - ANNEX I - ANNEXE I - ALLEGATO I - I PIELIKUMS - I PRIEDAS - I. MELLÉKLET - ANNESS I - BIJLAGE I - ZAŁĄCZNIK I - ANEXO I - ANEXA I - PRÍLOHA I - PRILOGA I - LIITE I - BILAGA I

Членове / Miembros / Členové / Medlemmer / Mitglieder / Liikmed / Μέλη / Members / Membres / Membri / Locekļi / Nariai / Tagok / Membri / Leden / Członkowie / Membros / Membri / Členovia / Člani / Jäsenet / Ledamöter

IRELAND

 

Mr Gerry BREEN

Member of Dublin City Council and Dublin Regional Authority

 

Ms Constance HANNIFFY

Member of Offaly County Council and Midland Regional Authority

 

Mr Denis LANDY

Member of South Tipperary County Council and South East Regional Authority

 

Mr Declan MCDONNELL

Member of Galway City Council and West Regional Authority

 

Mr Patrick MCGOWAN

Member of Donegal County Council and Border Regional Authority

 

Mr Brian MEANEY

Member of Clare County Council and Mid-West Regional Authority

 

Ms Michelle MULHERIN

Member of Mayo County Council and West Regional Authority

 

Mr Paul O’DONOGHUE

Member of Kerry County Council and South West Regional Authority

 

Ms Fiona O’LOUGHLIN

Member of Kildare County Council and Mid-East Regional Authority


ПРИЛОЖЕНИЕ II - ANEXO II - PŘÍLOHA II - BILAG II - ANHANG II - II LISA - ΠΑΡΑΡΤΗΜΑ IΙ - ANNEX II - ANNEXE II - ALLEGATO II - II PIELIKUMS - II PRIEDAS - II. MELLÉKLET - ANNESS II - BIJLAGE II - ZAŁĄCZNIK II - ANEXO II - ANEXA II - PRÍLOHA II - PRILOGA II - LIITE II - BILAGA II

Заместник-членове / Suplentes / Náhradníci / Suppleanter / Stellvertreter / Asendusliikmed / Αναπληρωτές / Alternates / Suppléants / Supplenti / Aizstājēji / Pakaitiniai nariai / Póttagok / Supplenti / Plaatsvervangers / Zastępcy / Suplentes / Supleanți / Náhradníci / Nadomestni člani / Varajäsenet / Suppleanter

DEUTSCHLAND

Herr Gustav BERGEMANN

Mitglied des Thüringer Landtags

IRELAND

 

Mr Terry BRENNAN

Member of Louth County Council

 

Ms Maria BYRNE

Member of Limerick City Council

 

Ms Mary FREEHILL

Member of Dublin City Council

 

Mr John LAHART

Member of South Dublin County Council

 

Mr Michael MCGREAL

Member of Roscommon County Council

 

Mr Niall MCNELIS

Member of Galway City Council

 

Mr John PENDER

Member of Carlow County Council

 

Ms Mary SHIELDS

Member of Cork City Council

 

Mr Barney STEELE

Member of Longford County Council


19.1.2010   

EN

Official Journal of the European Union

L 12/14


COMMISSION DECISION

of 9 December 2009

amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products

(notified under document C(2009) 9703)

(Text with EEA relevance)

(2010/30/EU)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on European Union and 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 16(f) thereof,

Having regard to the opinions of the European Medicines Agency, formulated on 10 January 2008 and 6 March 2008 by the Committee for Herbal Medicinal Products,

Whereas:

(1)

Eleutherococcus senticosus (Rupr. et Maxim.) Maxim’ and ‘Echinacea purpurea (L.) Moench’ comply with the requirements set out in Directive 2001/83/EC. ‘Eleutherococcus senticosus (Rupr. et Maxim.) Maxim’ and ‘Echinacea purpurea (L.) Moench’ can be considered as herbal substances, herbal preparations or combinations thereof.

(2)

It is therefore appropriate to include ‘Eleutherococcus senticosus (Rupr. et Maxim.) Maxim’ and ‘Echinacea purpurea (L.) Moench’ in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established in Annex I to 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

Decision 2008/911/EC is amended as follows:

1.

Annex I is amended in accordance with Annex I to this Decision;

2.

Annex II is amended in accordance with Annex II to this Decision.

Article 2

This Decision is addressed to the Member States.

Done at Brussels, 9 December 2009.

For the Commission

Günter VERHEUGEN

Vice-President


(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 328, 6.12.2008, p. 42.


ANNEX I

In Annex I to Decision 2008/911/EC, the following two substances are inserted after ‘Calendula officinalis L.’:

Echinacea purpurea (L.) Moench’

Eleutherococcus senticosus (Rupr. et Maxim.) Maxim’


ANNEX II

In Annex II to Decision 2008/911/EC, the following is inserted after the entry relating to ‘Calendula officinalis L’:

COMMUNITY LIST ENTRY ON ECHINACEA PURPUREA (L.) MOENCH, HERBA RECENS

Scientific name of the plant

Echinacea purpurea (L.) Moench

Botanical family

Asteraceae

Herbal substance

Purple coneflower herb

Common name in all EU official languages of herbal substance

 

BG (bălgarski): пурпурна ехинацея, пресен стрък

 

CS (čeština): čerstvá nať třapatky nachové

 

DA (dansk): Purpursolhat, frisk urt

 

DE (Deutsch): Purpursonnenhutkraut, frisch

 

EL (elliniká): Πόα Εχινάκεας της πορφυράς

 

EN (English): purple coneflower herb

 

ES (español): Equinácea purpúrea, partes aéreas incluidas sumidades floridas

 

ET (eesti keel): punane siilkübar

 

FI (suomi): kaunopunahattu, tuore verso

 

FR (français): parties aériennes fraîches d’échinacée pourpre

 

HU (magyar): bíbor kasvirág virágos hajtása

 

IT (italiano): Echinacea purpurea, pianta fresca

 

LT (lietuvių kalba): rausvažiedžių ežiuolių žolė

 

LV (latviešu valoda): purpursarkanās ehinacejas laksti

 

MT (malti): Echinacea Vjola

 

NL (nederlands): rood zonnehoedkruid

 

PL (polski): jeżówka purpurowa, świeże ziele

 

PT (português): Equinácea, partes aéreas floridas

 

RO (română): iarbã proaspãtã de Echinacea, pãlãria soarelui

 

SK (slovenčina): echinacea purpurová, čerstvá vňať

 

SL (slovenščina): sveža zel škrlatne ehinaceje

 

SV (svenska): röd solhatt, färsk ört

 

IS (íslenska): Sólhattur

 

NO (norsk): Rød solhatt

Herbal preparation(s)

Expressed juice and dried expressed juice from fresh flowering aerial parts.

European Pharmacopoeia monograph reference

N/A

Indication(s)

Traditional herbal medicinal product for treatment of small superficial wounds.

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

Type of tradition

European.

Specified strength

10 to 20 g/100 g of expressed juice or equivalent amount of dried expressed juice in liquid or semi-solid dosage forms.

Specified posology

Adolescents over the age of 12 years, adults, elderly

Small amount of ointment is applied on the affected area 2-3 times a day.

The use in children under 12 years of age is not recommended (see below “Special warnings and precautions for use”).

Route of administration

Cutaneous use.

Duration of use or any restrictions on the duration of use

Do not use the medicinal product for more than 1 week.

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

Any other information necessary for the safe use

Contra-indications

Hypersensitivity to the active substance or to plants of the Asteraceae (Compositae) family.

Special warnings and precautions for use

If signs of skin infection are observed, medical advice should be sought.

The use in children below 12 years of age is not recommended because a safe use has not been sufficiently documented.

Interactions with other medicinal products and other forms of interaction

None reported.

Pregnancy and lactation

There are no data on cutaneous use during pregnancy or lactation.

Products containing Echinacea should not be applied to the breast of breastfeeding women.

Effects on ability to drive and use machines

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

Undesirable effects

Hypersensitive reactions (local rash, contact dermatitis, eczema and angioedema of the lips) may occur.

The frequency is not known.

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

Overdose

No case of overdose has been reported.

COMMUNITY LIST ENTRY ON ELEUTHEROCOCCUS SENTICOSUS (RUPR. ET MAXIM.) MAXIM., RADIX

Scientific name of the plant

Eleutherococcus senticosus (Rupr. et Maxim.) Maxim.

Botanical family

Araliaceae

Herbal substance

Eleutherococcus root

Common name in all EU official languages of herbal substance

 

BG (bălgarski): елеутерокок, корен

 

CS (čeština): eleuterokokový kořen

 

DA (dansk): Russisk rod

 

DE (Deutsch): Taigawurzel

 

EL (elliniká): Pίζα Eλευθεροκόκκου

 

EN (English): Eleutherococcus root

 

ES (español): Eleuterococo, raíz de

 

ET (eesti keel): eleuterokokijuur

 

FI (suomi): venäjänjuuren juuri

 

FR (français): racine d’éleuthérocoque (racine de ginseng sibérien)

 

HU (magyar): Szibériai ginszeng gyökér (tajga gyökér)

 

IT (italiano): Eleuterococco radice

 

LT (lietuvių kalba): Eleuterokokų šaknys

 

LV (latviešu valoda): Eleiterokoka sakne

 

MT (malti): Għerq ta’ l-elewterokokku

 

NL (nederlands): Russische ginsengwortel

 

PL (polski): korzeń eleuterokoka

 

PT (português): Raiz de Ginseng Siberiano

 

RO (română): Rădăcină de ginseng siberian

 

SK (slovenčina): Všehojovcový koreň

 

SL (slovenščina): korenina elevterokoka

 

SV (svenska): Rysk rot

 

IS (íslenska): Síberíu ginseng, rót

 

NO (norsk): Russisk rot

Herbal preparation(s)

Comminuted herbal substance for preparation of a herbal tea

Liquid extract (1:1, ethanol 30-40 % v/v)

Dry extract (13-25: 1, ethanol 28-40 % v/v)

Dry extract (17-30: 1, ethanol 70 % v/v)

Dry aqueous extract (15-17:1)

Tincture (1:5, ethanol 40 % v/v)

European Pharmacopoeia monograph reference

Eleutherococcus — Eleutherococci radix (ref.: 01/2008: 1419 corrected 6.0)

Indication(s)

Traditional herbal medicinal product for symptoms of asthenia such as fatigue and weakness.

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

Type of tradition

Chinese, European.

Specified strength

Not applicable.

Specified posology

Adolescents over 12 years of age, adults, elderly

Herbal preparations.

Daily dose.

Comminuted herbal substance as herbal tea: 0,5-4 g.

Tea preparation: 0,5 to 4 g of comminuted herbal substance for infusion in 150 ml of boiling water.

Dosage frequency: 150 ml of tea infusion should be divided in one to three doses taken during the day.

Liquid extract: 2-3 ml.

Dry extracts (ethanol 28-70 % v/v) corresponding to 0,5-4 g dried root.

Dry aqueous extract (15-17:1): 90-180 mg.

Tincture: 10-15 ml.

The daily dose can be taken in one to three doses.

The use is not recommended in children under 12 years of age (see below “Special warnings and precautions for use”).

Route of administration

Oral use.

Duration of use or any restrictions on the duration of use

Not to be taken for more than 2 months.

If the symptoms persist for more than 2 weeks during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

Any other information necessary for the safe use

Contra-indications

Hypersensitivity to the active substance.

Arterial hypertension.

Special warnings and precautions for use

The use in children under 12 years of age is not recommended because sufficient experience is not available.

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

Interactions with other medicinal products and other forms of interaction

None reported.

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.

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

Insomnia, irritability, tachycardia and headaches may occur. The frequency is not known.

Overdose

No case of overdose has been reported.’