Source

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)

Decision · 4 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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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

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This Decision is addressed to the Member States.

Supplementary provisions

ANNEX ISupplementary provisions

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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 IISupplementary provisions

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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.’

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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