CELEX: 32008D0911
Language: en
Date: 2008-11-21 00:00:00
Title: 2008/911/EC: Commission Decision of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document number C(2008) 6933) (Text with EEA relevance)

6.12.2008   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 328/42
            
         
      COMMISSION DECISION
   
   of 21 November 2008
   establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products
   (notified under document number C(2008) 6933)
   (Text with EEA relevance)
   (2008/911/EC)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   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 7 September 2007 by the Committee for Herbal Medicinal Products,
   Whereas:
   
               (1)
            
            
               
                  Foeniculum vulgare Miller subsp. vulgare var. vulgare and Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung comply with the requirements set out in Directive 2001/83/EC. Foeniculum vulgare Miller subsp. vulgare var. vulgare and Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung can be considered as herbal substances, herbal preparations and/or combinations thereof.
            
         
               (2)
            
            
               It is therefore appropriate to establish a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products including the entry of Foeniculum vulgare Miller subsp. vulgare var. vulgare and the entry of Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung.
            
         
               (3)
            
            
               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
   A list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products is established in Annex I including the entry of Foeniculum vulgare Miller subsp. vulgare var. vulgare and the entry of Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung.
   Article 2
   The indications, the specified strengths and the posology, the route of administration and any other information necessary for the safe use as a traditional medicinal product relevant for Foeniculum vulgare Miller subsp. vulgare var. vulgare and Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung are set out in Annex II to this decision.
   Article 3
   This Decision is addressed to the Member States.
   
      Done at Brussels, 21 November 2008.
      
         
            For the Commission
         
         Günter VERHEUGEN
         
         
            Vice-President
         
      
   
   
      (1)  OJ L 311, 28.11.2001, p. 67.
   
      ANNEX I
      List of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established in accordance with Article 16f of Directive 2001/83/EC as amended by Directive 2004/24/EC
      
                   
               
               
                  
                     Foeniculum vulgare Miller subsp. vulgare var. vulgare (bitter fennel fruit)
               
            
                   
               
               
                  
                     Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung (sweet fennel fruit)
               
            
   
      ANNEX II
      A.   COMMUNITY LIST ENTRY ON FOENICULUM VULGARE MILLER SUBSP. VULGARE VAR. VULGARE, FRUCTUS
      Scientific name of the plant
      
         Foeniculum vulgare Miller subsp. vulgare var. vulgare
      
      Botanical family
      Apiaceae
      Herbal substance
      Fennel, bitter
      Common name in all EU official languages of herbal substance
      
                   
               
               
                  BG (bălgarski): Горчиво резене, плод
               
            
                   
               
               
                  CS (čeština): Plod fenyklu obecného pravého
               
            
                   
               
               
                  DA (dansk): Fennikel, bitter
               
            
                   
               
               
                  DE (Deutsch): Bitterer Fenchel
               
            
                   
               
               
                  EL (elliniká): Μαραθόσπορος πικρός
               
            
                   
               
               
                  EN (English): Bitter fennel, fruit
               
            
                   
               
               
                  ES (español): Hinojo amargo, fruto de
               
            
                   
               
               
                  ET (eesti keel): Mõru apteegitill, vili
               
            
                   
               
               
                  FI (suomi): Karvasfenkoli, hedelmä
               
            
                   
               
               
                  FR (français): Fruit de fenouil amer
               
            
                   
               
               
                  HU (magyar): Keserűédeskömény-termés
               
            
                   
               
               
                  IT (italiano): Finocchio amaro (o selvatico), frutto
               
            
                   
               
               
                  LT (lietuvių kalba): Karčiųjų pankolių vaisiai
               
            
                   
               
               
                  LV (latviešu valoda): Rūgtā fenheļa augļi
               
            
                   
               
               
                  MT (malti): Bużbież morr, frotta
               
            
                   
               
               
                  NL (nederlands): Venkelvrucht, bitter
               
            
                   
               
               
                  PL (polski): Owoc kopru włoskiego (odmiana gorzka)
               
            
                   
               
               
                  PT (português): Fruto de funcho amargo
               
            
                   
               
               
                  RO (română): Fruct de fenicul amar
               
            
                   
               
               
                  SK (slovenčina): Feniklový plod horký
               
            
                   
               
               
                  SL (slovenščina): Plod grenkega navadnega komarčka
               
            
                   
               
               
                  SV (svenska): Bitterfänkål, frukt
               
            
                   
               
               
                  
                     IS (íslenska): Bitur fennel aldin
                  
               
            
                   
               
               
                  
                     NO (norsk): Fenikkel, bitter
                  
               
            Herbal preparation(s)
      Fennel, bitter, dried comminuted (1) fruit.
      European Pharmacopoeia monograph reference
      Foeniculi amari fructus (01/2005:0824).
      Indication(s)
      
                  (a)
               
               
                  Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence.
               
            
                  (b)
               
               
                  Traditional herbal medicinal product for symptomatic treatment of minor spasm associated with menstrual periods.
               
            
                  (c)
               
               
                  Traditional herbal medicinal product used as an expectorant in cough associated with cold.
               
            The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.
      Type of tradition
      European, Chinese.
      Specified strength
      Please see ‘Specified posology’.
      Specified posology
      Adults
      Single dose
      1,5 to 2,5 g of (freshly (2)) comminuted fennel fruits with 0,25 l of boiling water (brew for 15 minutes) three times daily as a herbal tea.
      Adolescents over 12 years of age, indication (a)
      
      Adult dose
      Children between four and 12 years of age, indication (a)
      
      Average daily dose
      3-5 g of (freshly) comminuted fruits as a herbal tea, in three divided doses, for short-term use in mild transitory symptoms only (less than one week).
      The use in children under four years of age is not recommended (see section ‘Special warnings and precautions for use’).
      Route of administration
      Oral use.
      Duration of use or any restrictions on the duration of use
      Adults
      Adolescents over 12 years of age, indication (a)
      
      Not to be taken for more than two weeks.
      Children between four and 12 years of age, indication (a)
      
      For short-term use in mild transitory symptoms only (less than one week).
      If the symptoms persist during the use of the medicinal product, a doctor or a qualified health-care practitioner should be consulted.
      Any other information necessary for the safe use
      Contraindications
      Hypersensitivity to the active substance or to Apiaceae (Umbelliferae) (aniseed, caraway, celery, coriander and dill) or to anethole.
      Special warnings and precautions for use
      The use in children under four years of age is not recommended due to the lack of adequate data and a paediatrician’s advice should be sought.
      Interactions with other medicinal products and other forms of interaction
      None reported.
      Pregnancy and lactation
      There are no data from the use of fennel fruit in pregnant patients.
      It is unknown if fennel constituents are excreted in human breast milk.
      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
      Allergic reactions to fennel, affecting the skin or the respiratory system may occur. The frequency is not known.
      If other adverse reactions not mentioned above occur, a doctor or a qualified health-care practitioner should be consulted.
      Overdose
      No case of overdose has been reported.
      Pharmaceutical particulars (if necessary)
      
      Not applicable.
      Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)
      
      Not applicable.
      B.   COMMUNITY LIST ENTRY ON FOENICULUM VULGARE MILLER SUBSP. VULGARE VAR. DULCE (MILLER) THELLUNG, FRUCTUS
      Scientific name of the plant
      
         Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung
      Botanical family
      Apiaceae
      Herbal substance
      Fennel, sweet
      Common name in all EU official languages of herbal substance
      
                   
               
               
                  BG (bălgarski): Сладко резене, плод
               
            
                   
               
               
                  CS (čeština): Plod fenyklu obecného sladkého
               
            
                   
               
               
                  DA (dansk): Fennikel, sød
               
            
                   
               
               
                  DE (Deutsch): Süßer Fenchel
               
            
                   
               
               
                  EL (elliniká): Μαραθόσπορος γλυκύς
               
            
                   
               
               
                  EN (English): Sweet fennel, fruit
               
            
                   
               
               
                  ES (español): Hinojo dulce, fruto de
               
            
                   
               
               
                  ET (eesti keel): Magus apteegitill, vili
               
            
                   
               
               
                  FI (suomi): Makea fenkoli, hedelmä
               
            
                   
               
               
                  FR (français): Fruit de fenouil doux
               
            
                   
               
               
                  HU (magyar): Édesköménytermés
               
            
                   
               
               
                  IT (italiano): Finocchio dolce (o romano), frutto
               
            
                   
               
               
                  LT (lietuvių kalba): Saldžiųjų pankolių vaisiai
               
            
                   
               
               
                  LV (latviešu valoda): Saldā fenheļa augļi
               
            
                   
               
               
                  MT (malti): Bużbież ħelu, frotta
               
            
                   
               
               
                  NL (nederlands): Venkelvrucht, zoet
               
            
                   
               
               
                  PL (polski): Owoc kopru włoskiego (odmiana słodka)
               
            
                   
               
               
                  PT (português): Fruto de funcho doce
               
            
                   
               
               
                  RO (română): Fruct de fenicul dulce
               
            
                   
               
               
                  SK (slovenčina): Feniklový plod sladký
               
            
                   
               
               
                  SL (slovenščina): Plod sladkega navadnega komarčka
               
            
                   
               
               
                  SV (svenska): Sötfänkål, frukt
               
            
                   
               
               
                  
                     IS (íslenska): Sæt fennel aldin
                  
               
            
                   
               
               
                  
                     NO (norsk): Fenikkel, søt
                  
               
            Herbal preparation(s)
      Fennel, sweet, dried comminuted (3) or powdered fruit.
      European Pharmacopoeia monograph reference
      Foeniculi dulcis fructus (01/2005:0825).
      Indication(s)
      
                  (a)
               
               
                  Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence.
               
            
                  (b)
               
               
                  Traditional herbal medicinal product for symptomatic treatment of minor spasm associated with menstrual periods.
               
            
                  (c)
               
               
                  Traditional herbal medicinal product used as an expectorant in cough associated with cold.
               
            The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.
      Type of tradition
      European, Chinese.
      Specified strength
      Please see ‘Specified posology’.
      Specified posology
      Adults
      Single dose
      1,5 to 2,5 g of (freshly (4)) comminuted fennel fruits with 0,25 l of boiling water (brew for 15 minutes) three times daily as a herbal tea.
      Fennel powder: 400 mg three times a day (with a maximum of 2 g daily).
      Adolescents over 12 years of age, indication (a)
      
      Adult dose
      Children between four and 12 years of age, indication (a)
      
      Average daily dose
      3-5 g of (freshly) comminuted fruits as a herbal tea, in three divided doses, for short-term use in mild transitory symptoms only (less than one week).
      The use in children under four years of age is not recommended (see section ‘Special warnings and precautions for use’).
      Route of administration
      Oral use.
      Duration of use or any restrictions on the duration of use
      Adults
      Adolescents over 12 years of age, indication (a)
      
      Not to be taken for more than two weeks.
      Children between four and 12 years of age, indication (a)
      
      For short-term use in mild transitory symptoms only (less than one week).
      If the symptoms persist during the use of the medicinal product, a doctor or a qualified health-care practitioner should be consulted.
      Any other information necessary for the safe use
      Contraindications
      Hypersensitivity to the active substance or to Apiaceae (Umbelliferae) (aniseed, caraway, celery, coriander and dill) or to anethole.
      Special warnings and precautions for use
      The use in children under four years of age is not recommended due to the lack of adequate data and a paediatrician’s advice should be sought.
      Interactions with other medicinal products and other forms of interaction
      None reported.
      Pregnancy and lactation
      There are no data from the use of fennel fruit in pregnant patients.
      It is unknown if fennel constituents are excreted in human breast milk.
      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
      Allergic reactions to fennel, affecting the skin or the respiratory system, may occur. The frequency is not known.
      If other adverse reactions not mentioned above occur, a doctor or a qualified health-care practitioner should be consulted.
      Overdose
      No case of overdose has been reported.
      Pharmaceutical particulars (if necessary)
      
      Not applicable.
      Pharmacological effects or efficacy plausible on the basis of long-standing use and experience (if necessary for the safe use of the product)
      
      Not applicable.
      
         (1)  ‘Comminuted fruit’ is intended to cover also ‘crushed fruit’.
      
         (2)  For commercial preparation of comminuted fennel fruits the applicant must carry out appropriate stability testing related to the content of essential oil components.
      
         (3)  ‘Comminuted fruit’ is intended to cover also ‘crushed fruit’.
      
         (4)  For commercial preparation of comminuted or powdered fennel fruits the applicant must carry out appropriate stability testing related to the content of essential oil components.