Commission Implementing Decision (EU) 2026/334 of 13 February 2026 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products with regards to Foeniculum vulgare (notified under document C(2026) 808)

ANNEX
ANNEX
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 , FRUCTUS
Scientific name of the plant
Foeniculum vulgare  Miller subsp.  vulgare  var.  vulgare
Botanical family
Apiaceae
Herbal substance
Bitter fennel, fruit
Common name of herbal substance in all EU official languages
BG (bulgarski): Горчиво резене, плод
LT (lietuvių kalba): Kartieji pankolių, vaisiai
CS (čeština): Plod fenyklu obecného pravého
LV (latviešu valoda): Rūgtā fenheļa, augļi
DA (dansk): Fennikel bitter
MT (malti): Bużbież morr, frotta
DE (Deutsch): Bitterer Fenchel
NL (nederlands): Bittere venkel, vrucht
EL (elliniká): Πικρού μάραθου καρπός
PL (polski): Koper włoski odmiany gorzkiej, owoc
EN (English): Bitter Fennel
PT (português): Funcho-amargo, fruto
ES (español): Hinojo amargo, fruto
RO (română): Fenicul amar, fruct
ET (eesti keel): Mõru apteegitill, vili
SK (slovenčina): Plod fenikla horkého
FI (suomi): Karvasfenkoli, hedelmä
SL (slovenščina): Plod grenkega navadnega komarčka
FR (français): Fenouil amer, fruit
SV (svenska): Bitterfänkål, frö
HR (hrvatski): Komorač gorki, plod
IS (íslenska): Bitur fennel aldin
HU (magyar): Keserű édeskömény, termés
NO (norsk): Bitter fennikel
IT (italiano): Finocchio amaro, frutto
Herbal preparation(s)
Not applicable
European Pharmacopoeia monograph reference
Bitter fennel – Foeniculi amari fructus (04/2013:0824)
Indications
Indication (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 tradition
European
Specified strength
Please see “Specified posology”
Specified posology
Indications (1) and (3)
Adults and adolescents
Single dose
Herbal 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 g
Children between 4 and 12 years of age
Single dose
Herbal 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 g
For 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 adolescents
Single dose
Herbal 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 g
The 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 administration
Oral use
Duration of use or any restrictions on the duration of use
Indications (1), (2) and (3)
Adults and adolescents
Not to be taken for more than 2 weeks.
Indications (1) and (3)
Children between 4 and 12 years of age
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) 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 use
Indications (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 interaction
None reported
Fertility, 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.
There is evidence that trans -anethole is excreted in human breast milk.
No fertility data available.
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
In 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 experience
Not 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., FRUCTUS
Scientific name of the plant
Foeniculum vulgare Miller subsp. vulgare var. dulce (Mill.) Batt. & Trab.
Botanical family
Apiaceae
Herbal substance
Sweet fennel, fruit
Common name of herbal substance in all EU official languages
BG (bulgarski): Сладко резене, плод
LT (lietuvių kalba): Saldieji pankolių, vaisiai
CS (čeština): Plod fenyklu obecného sladkého
LV (latviešu valoda): Saldā fenheļa, augļi
DA (dansk): Fennikel sød
MT (malti): Bużbież ħelu, frotta
DE (Deutsch): Süßer Fenchel
NL (nederlands): Zoete venkel, vrucht
EL (elliniká): Γλυκού μάραθου καρπός
PL (polski): Koper włoski odmiany słodkiej, owoc
EN (English): Sweet fennel, fruit
PT (português): Funcho-doce, fruto
ES (español): Hinojo dulce, fruto
RO (română): Fenicul dulce, fruct
ET (eesti keel): Magus apteegitill, vili
SK (slovenčina): Plod fenikla sladkého
FI (suomi): Makeafenkoli, hedelmä
SL (slovenščina): Plod sladkega navadnega komarčka
FR (français): Fenouil doux, fruit
SV (svenska): Sötfänkål, frö
HR (hrvatski): Komorač slatki, plod
IS (íslenska): Sæt fennel aldin
HU (magyar): Édeskömény termés
NO (norsk): Søt fennikel
IT (italiano): Finocchio dolce, frutto
Herbal preparation(s)
Not applicable
European Pharmacopoeia monograph reference
Sweet fennel – Foeniculi dulcis fructus (04/2011:0825))
Indications
Indication (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 tradition
European
Specified strength
Please see “Specified posology”
Specified posology
Indications (1) and (3)
Adults and adolescents
Single dose
Herbal 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 g
Children between 4 and 12 years of age
Single dose
Herbal 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 g
For 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 adolescents
Single dose
Herbal 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 g
The 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 administration
Oral use
Duration of use or any restrictions on the duration of use
Indications (1), (2) and (3)
Adults and adolescents
Not to be taken for more than 2 weeks.
Indications (1) and (3)
Children between 4 and 12 years of age
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) 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 use
Indications (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 interaction
None reported
Fertility, 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.
There is evidence that trans- anethole is excreted in human breast milk.
No fertility data available.
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
In 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 experience
Not 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 .’.
Commission Implementing Decision (EU) 2026/334 of 13 February 2026 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products with regards to Foeniculum vulgare (notified under document C(2026) 808)

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