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)

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.

ANNEX I

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

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.’

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)

Schedules & Appendices

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