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Document 02008D0911-20100119

    Consolidated text: 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)

    ELI: http://data.europa.eu/eli/dec/2008/911/2010-01-19

    2008D0911 — EN — 19.01.2010 — 001.001


    This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

    ►B

    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)

    (OJ L 328, 6.12.2008, p.42)

    Amended by:

     

     

    Official Journal

      No

    page

    date

    ►M1

    COMMISSION DECISION of 28 July 2009

      L 11

    12

    16.1.2010

    ►M2

    COMMISSION DECISION of 9 December 2009

      L 12

    14

    19.1.2010




    ▼B

    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.




    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

    ▼M1

    Calendula officinalis L

    ▼M2

    Echinacea purpurea (L.) Moench

    Eleutherococcus senticosus (Rupr. et Maxim.) Maxim

    ▼B

    Foeniculum vulgare Miller subsp. vulgare var. vulgare (bitter fennel fruit)

    Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung (sweet fennel fruit)

    ▼M1

    Pimpinella anisum L

    ▼B




    ANNEX II

    ▼M1

    COMMUNITY LIST ENTRY ON CALENDULA OFFICINALIS L

    Scientific name of the plant

    Calendula officinalis L.

    Botanical family

    Asteraceae

    Herbal substance

    Calendula flower

    Common name in all EU official languages of herbal substance

    BG (bălgarski): Невен, цвят

    CS (čeština): Měsíčkový květ

    DA (dansk): Morgenfrueblomst

    DE (Deutsch): Ringelblumenblüten

    EL (elliniká): Άνθος καλέντουλας

    EN (English): Calendula flower

    ES (español): Flor de caléndula

    ET (eesti keel): Saialilleõisik

    FI (suomi): Tarhakehäkukan kukka

    FR (français): Souci

    HU (magyar): A körömvirág virága

    IT (italiano): Calendula fiore

    LT (lietuvių kalba): Medetkų žiedai

    LV (latviešu valoda): Kliņģerītes ziedi

    MT (malti): Fjura calendula

    NL (nederlands): Goudsbloem

    PL (polski): Kwiat nagietka

    PT (português): Flor de calêndula

    RO (română): Floare de gălbenele (calendula)

    SK (slovenčina): Nechtíkový kvet

    SL (slovenščina): Cvet vrtnega ognjiča

    SV (svenska): Ringblomma, blomma

    IS (íslenska): Morgunfrú, blóm

    NO (norsk): Ringblomst

    Herbal preparation(s)

    A. Liquid extract (DER 1:1), extraction solvent ethanol 40-50 % (v/v).

    B. Liquid extract (DER 1:1,8-2,2), extraction solvent ethanol 40-50 % (v/v).

    C. Tincture (DER 1:5), extraction solvent ethanol 70-90 % (v/v).

    European Pharmacopoeia monograph reference

    Calendula flower – Calendulae flos (01/2005:1297)

    Indication(s)

    (a) Traditional herbal medicinal product for the symptomatic treatment of minor inflammations of the skin (such as sunburn) and as an aid in healing of minor wounds.

    (b) Traditional herbal medicinal product for the symptomatic treatment of minor inflammations in the mouth or the throat.

    The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.

    Type of tradition

    European

    Specified strength

    Please see ‘Specified posology’.

    Specified posology

    Herbal preparations:

    A. Liquid extract (DER 1:1)

    In semi-solid dosage forms: amount equivalent to 2-10 % herbal substance.

    B. Liquid extract (DER 1:1,8-2,2)

    In semi-solid dosage forms: amount equivalent to 2-5 % herbal substance.

    C. Tincture (DER 1:5)

    In compresses diluted at least 1:3 with freshly boiled water.

    In semi-solid dosage forms: amount equivalent to 2-10 % herbal substance.

    As a gargle or mouth rinse in a 2 % solution.

    2 to 4 times daily

    Indication (a)

    The use is not recommended in children under 6 years of age (see below ‘Special warnings and precautions for use’).

    Indication (b)

    The use in children under 12 years of age is not recommended because there is no experience available (see below ‘Special warnings and precautions for use’).

    Route of administration

    Cutaneous and oromucosal use.

    Duration of use or any restrictions on the duration of use

    Compresses: remove after 30-60 minutes

    All herbal preparations: If the symptoms persist after 1 week 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 members of the Asteraceae (Compositae) family.

    Special warnings and precautions for use

    Indication (a)

    The use in children under 6 years of age is not recommended because there is no experience available.

    Indication (b)

    The use in children under 12 years of age is not recommended because there is no experience available.

    If signs of skin infection are observed, a doctor or a qualified health care 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

    Not relevant.

    Undesirable effects

    Skin sensitisation. 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

    None reported.

    ▼M2

    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.

    ▼B

    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 ( 2 ) 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 ( 3 )) 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 ( 4 ) 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 ( 5 )) 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.

    ▼M1

    COMMUNITY LIST ENTRY ON PIMPINELLA ANISUM L

    Scientific name of the plant

    Pimpinella anisum L.

    Botanical family

    Apiaceae

    Herbal substance

    Aniseed

    Common name in all EU official languages of herbal substance

    BG (bălgarski): Анасон, плод

    CS (čeština): Anýzový plod

    DA (dansk): Anisfrø

    DE (Deutsch): Anis

    EL (elliniká): Γλυκάνισο

    EN (English): Aniseed

    ES (español): Fruto de anís

    ET (eesti keel): Aniis

    FI (suomi): Anis

    FR (français): Anis (fruit d)

    HU (magyar): Ánizsmag

    IT (italiano): Anice (Anice verde), frutto

    LT (lietuvių kalba): Anyžių sėklos

    LV (latviešu valoda): Anīsa sēklas

    MT (malti): Frotta tal-Anisi

    NL (nederlands): Anijsvrucht

    PL (polski): Owoc anyżu

    PT (português): Anis

    RO (română): Fruct de anason

    SK (slovenčina): Anízový plod

    SL (slovenščina): Plod vrtnega janeža

    SV (svenska): Anis

    IS (íslenska): Anís

    NO (norsk): Anis

    Herbal preparation(s)

    Dried aniseed, comminuted or crushed

    European Pharmacopoeia monograph reference

    Anisi fructus (01/2005:0262)

    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 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

    Specified strength

    Please see ‘Specified posology’

    Specified posology

    Adolescents over 12 years of age, adults, elderly:

    Indications (a) and (b)

    1 to 3,5 g of whole or (freshly ( 6 )) comminuted or crushed aniseed in 150 ml of boiling water as a herbal tea

    3 times daily

    The use in children under 12 years is not recommended 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 weeks.

    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) (caraway, celery, coriander, dill and fennel) or to anethole.

    Special warnings and precautions for use

    The use is not recommended in children under 12 years of age due to the lack of adequate data for safety assessment.

    Interactions with other medicinal products and other forms of interaction

    None reported.

    Pregnancy and lactation

    There are no data from the use of aniseed in pregnant patients.

    It is unknown if aniseed 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 aniseed 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.



    ( 1 ) OJ L 311, 28.11.2001, p. 67.

    ( 2 ) ‘Comminuted fruit’ is intended to cover also ‘crushed fruit’.

    ( 3 ) For commercial preparation of comminuted fennel fruits the applicant must carry out appropriate stability testing related to the content of essential oil components.

    ( 4 ) ‘Comminuted fruit’ is intended to cover also ‘crushed fruit’.

    ( 5 ) 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.

    ( 6 ) For commercial preparations of comminuted or crushed aniseed the applicant must carry out appropriate stability testing related to the content of essential oil components.

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