CELEX: 32010D0030
Language: en
Date: 2009-12-09 00:00:00
Title: 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)

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.’