2010/30/: 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)
Date: 2009-12-09
Institutions: European Commission
Subjects: crop production, medical plant, medicinal product, pharmaceutical industry, pharmaceutical legislation








L_2010012EN.01001401.xml










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.’