Contents
THE EUROPEAN COMMISSION,Having regard 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 usenote, and in particular Article 16f thereof,Whereas:
(1)In 2007, the European Medicines Agency established in its opinions that Foeniculum vulgare Miller subsp. vulgare var. vulgare, fructus and Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung, fructus complied with the requirements set out in Directive 2001/83/EC as herbal substances, herbal preparations or combinations thereof within the meaning of that Directive and were therefore included in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/ECnote.
(2)The Committee on Herbal Medicinal Products of the European Medicines Agency has reviewed the list entries Foeniculum vulgare Miller subsp. vulgare var. vulgare, fructus and Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung, fructus and adopted two respective opinions to change those entries. Based on those opinions, it is necessary to amend the scientific and common name of those herbal substances in EU official languages, the description of herbal preparations, the reference to the European Pharmacopoeia monograph, the numbering of the indications, the type of tradition, the specified posology, the duration of use, pharmaceutical particulars and the information on the safe use, including contraindications, special warnings and precautions for use with respect to fertility, pregnancy and lactation.
(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#
Annex II to Decision 2008/911/EC is amended in accordance with the Annex to this Decision.
In Annex II, the Community list entry on Foeniculum vulgare Miller subsp. vulgare var. vulgare, fructus and the Community list entry on Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung, fructus are replaced by the following:
‘A.UNION LIST ENTRY ON FOENICULUM VULGARE MILLER SUBSP. VULGARE VAR. VULGARE, FRUCTUSScientific name of the plantFoeniculum vulgare Miller subsp. vulgare var. vulgareBotanical familyApiaceaeHerbal substanceBitter fennel, fruitCommon name of herbal substance in all EU official languagesBG (bulgarski): Горчиво резене, плод | LT (lietuvių kalba): Kartieji pankolių, vaisiaiCS (čeština): Plod fenyklu obecného pravého | LV (latviešu valoda): Rūgtā fenheļa, augļiDA (dansk): Fennikel bitter | MT (malti): Bużbież morr, frottaDE (Deutsch): Bitterer Fenchel | NL (nederlands): Bittere venkel, vruchtEL (elliniká): Πικρού μάραθου καρπός | PL (polski): Koper włoski odmiany gorzkiej, owocEN (English): Bitter Fennel | PT (português): Funcho-amargo, frutoES (español): Hinojo amargo, fruto | RO (română): Fenicul amar, fructET (eesti keel): Mõru apteegitill, vili | SK (slovenčina): Plod fenikla horkéhoFI (suomi): Karvasfenkoli, hedelmä | SL (slovenščina): Plod grenkega navadnega komarčkaFR (français): Fenouil amer, fruit | SV (svenska): Bitterfänkål, fröHR (hrvatski): Komorač gorki, plod | IS (íslenska): Bitur fennel aldinHU (magyar): Keserű édeskömény, termés | NO (norsk): Bitter fennikelIT (italiano): Finocchio amaro, frutto |Herbal preparation(s)Not applicableEuropean Pharmacopoeia monograph referenceBitter fennel – Foeniculi amari fructus (04/2013:0824)IndicationsIndication (1)Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence.Indication (2)Traditional herbal medicinal product for symptomatic treatment of minor spasm associated with menstrual periods.Indication (3)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 traditionEuropeanSpecified strengthPlease see “Specified posology”Specified posologyIndications (1) and (3)Adults and adolescentsSingle doseHerbal tea: 1,5 g of herbal substance in 250 ml of boiling water (steep for 15 minutes) as a herbal infusion, 3 times daily.Recommended daily dose: 4,5 gChildren between 4 and 12 years of ageSingle doseHerbal tea: 1,0 g of herbal substance in 100 ml of boiling water (steep for 15 minutes) as a herbal infusion, 3 times daily.Recommended daily dose: 3,0 gFor further information on the use in children between 4 and 12 years of age, see section “Special warnings and precautions for use”.The use is not recommended in children under 4 years of age (see section “Special warnings and precautions for use”).See section “Pharmaceutical particulars” for content of estragole.Indication (2)Adults and adolescentsSingle doseHerbal tea: 1,5 g of herbal substance in 250 ml of boiling water (steep for 15 minutes) as a herbal infusion, 3 times daily.Recommended daily dose: 4,5 gThe use in children under 12 years of age is not recommended (see section “Special warnings and precautions for use”).See section “Pharmaceutical particulars” for content of estragole.Route of administrationOral useDuration of use or any restrictions on the duration of useIndications (1), (2) and (3)Adults and adolescentsNot to be taken for more than 2 weeks.Indications (1) and (3)Children between 4 and 12 years of ageFor 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 useContraindicationsHypersensitivity to the active substance or to Apiaceae (Umbelliferae) family (aniseed, caraway, celery, coriander and dill) or to anethole.Hypersensitivity to mugwort pollen, due to cross-reactivity with fennel.Special warnings and precautions for useIndications (1) and (3)The use in children between 4 and 12 years of age is not recommended if the daily intake of estragole exceeds the guidance value of 1,0 μg/kg bw, unless justified by a risk assessment based on adequate safety data.The use is not recommended in children under 4 years of age due to the lack of adequate data.Indication (2)The use in children under 12 years of age has not been established due to lack of adequate data.If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.Interactions with other medicinal products and other forms of interactionNone reportedFertility, pregnancy, and lactationSafety during pregnancy and lactation has not been established.In the absence of sufficient data, the use during pregnancy and lactation is not recommended.There is evidence that trans-anethole is excreted in human breast milk.No fertility data available.Effects on ability to drive and use machinesNo studies on the effect on the ability to drive and use machines have been performed.Undesirable effectsAllergic 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.OverdoseNo case of overdose has been reported.Pharmaceutical particularsIn the general population exposure to estragole should be kept as low as practically achievable.In pregnant and breast-feeding women, the daily intake of estragole should be below 0,05 mg/person per day.In children below 12 years of age, the daily intake of estragole should be below 1,0 μg/kg bw.For further details see the “Public statement on the use of herbal medicinal products containing estragole”*.Pharmacological effects or efficacy plausible on the basis of long-standing use and experienceNot applicable.*“Public statement on the use of herbal medicinal products containing estragole” of 12 May 2023 of the Committee on Herbal Medicinal Products, EMA/HMPC/137212/2005, Rev 1 Corr 1, available at: https://www.ema.europa.eu/en/documents/other/public-statement-use-herbal-medicinal-products-containing-estragole-revision-1_en.pdf.B.UNION LIST ENTRY ON FOENICULUM VULGARE MILLER SUBSP. VULGARE VAR. DULCE (MILL.) BATT. & TRAB., FRUCTUSScientific name of the plantFoeniculum vulgare Miller subsp. vulgare var. dulce (Mill.) Batt. & Trab.Botanical familyApiaceaeHerbal substanceSweet fennel, fruitCommon name of herbal substance in all EU official languagesBG (bulgarski): Сладко резене, плод | LT (lietuvių kalba): Saldieji pankolių, vaisiaiCS (čeština): Plod fenyklu obecného sladkého | LV (latviešu valoda): Saldā fenheļa, augļiDA (dansk): Fennikel sød | MT (malti): Bużbież ħelu, frottaDE (Deutsch): Süßer Fenchel | NL (nederlands): Zoete venkel, vruchtEL (elliniká): Γλυκού μάραθου καρπός | PL (polski): Koper włoski odmiany słodkiej, owocEN (English): Sweet fennel, fruit | PT (português): Funcho-doce, frutoES (español): Hinojo dulce, fruto | RO (română): Fenicul dulce, fructET (eesti keel): Magus apteegitill, vili | SK (slovenčina): Plod fenikla sladkéhoFI (suomi): Makeafenkoli, hedelmä | SL (slovenščina): Plod sladkega navadnega komarčkaFR (français): Fenouil doux, fruit | SV (svenska): Sötfänkål, fröHR (hrvatski): Komorač slatki, plod | IS (íslenska): Sæt fennel aldinHU (magyar): Édeskömény termés | NO (norsk): Søt fennikelIT (italiano): Finocchio dolce, frutto |Herbal preparation(s)Not applicableEuropean Pharmacopoeia monograph referenceSweet fennel – Foeniculi dulcis fructus (04/2011:0825))IndicationsIndication (1)Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence.Indication (2)Traditional herbal medicinal product for symptomatic treatment of minor spasm associated with menstrual periods.Indication (3)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 traditionEuropeanSpecified strengthPlease see “Specified posology”Specified posologyIndications (1) and (3)Adults and adolescentsSingle doseHerbal tea: 1,5 g of herbal substance in 250 ml of boiling water (steep for 15 minutes) as a herbal infusion, 3 times daily.Recommended daily dose: 4,5 gChildren between 4 and 12 years of ageSingle doseHerbal tea: 1,0 g of herbal substance in 100 ml of boiling water (steep for 15 minutes) as a herbal infusion, 3 times daily.Recommended daily dose: 3,0 gFor further information on the use in children between 4 and 12 years of age, see section “Special warnings and precautions for use”.The use is not recommended in children under 4 years of age (see section “Special warnings and precautions for use”).See section “Pharmaceutical particulars” for content of estragole.Indication (2)Adults and adolescentsSingle doseHerbal tea: 1,5 g of herbal substance in 250 ml of boiling water (steep for 15 minutes) as a herbal infusion, 3 times daily.Recommended daily dose: 4,5 gThe use in children under 12 years of age is not recommended (see section “Special warnings and precautions for use”).See section “Pharmaceutical particulars” for content of estragole.Route of administrationOral useDuration of use or any restrictions on the duration of useIndications (1), (2) and (3)Adults and adolescentsNot to be taken for more than 2 weeks.Indications (1) and (3)Children between 4 and 12 years of ageFor 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 useContraindicationsHypersensitivity to the active substance or to Apiaceae (Umbelliferae) family (aniseed, caraway, celery, coriander and dill) or to anethole.Hypersensitivity to mugwort pollen, due to cross-reactivity with fennel.Special warnings and precautions for useIndications (1) and (3)The use in children between 4 and 12 years of age is not recommended if the daily intake of estragole exceeds the guidance value of 1,0 μg/kg bw, unless justified by a risk assessment based on adequate safety data.The use is not recommended in children under 4 years of age due to the lack of adequate data.Indication (2)The use in children under 12 years of age has not been established due to lack of adequate data.If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.Interactions with other medicinal products and other forms of interactionNone reportedFertility, pregnancy and lactationSafety during pregnancy and lactation has not been established.In the absence of sufficient data, the use during pregnancy and lactation is not recommended.There is evidence that trans-anethole is excreted in human breast milk.No fertility data available.Effects on ability to drive and use machinesNo studies on the effect on the ability to drive and use machines have been performed.Undesirable effectsAllergic 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.OverdoseNo case of overdose has been reported.Pharmaceutical particularsIn the general population exposure to estragole should be kept as low as practically achievable.In pregnant and breast-feeding women, the daily intake of estragole should be below 0,05 mg/person per day.In children below 12 years of age, the daily intake of estragole should be below 1,0 μg/kg bw.For further details see the “Public statement on the use of herbal medicinal products containing estragole”*.Pharmacological effects or efficacy plausible on the basis of long-standing use and experienceNot applicable.*“Public statement on the use of herbal medicinal products containing estragole” of 12 May 2023 of the Committee on Herbal Medicinal Products, (HMPC) EMA/HMPC/137212/2005, Rev 1 Corr 1, available at: https://www.ema.europa.eu/en/documents/other/public-statement-use-herbal-medicinal-products-containing-estragole-revision-1_en.pdf.’.
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