Commission Implementing Decision (EU) 2026/334of 13 February 2026amending 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)(Text with EEA relevance)

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) (Text with EEA relevance) 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 use OJ L 311, 28.11.2001, p. 67, ELI: http://data.europa.eu/eli/dir/2001/83/oj. , 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/EC Commission Decision 2008/911/EC of 21 November 2008 establishing of a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (OJ L 328, 6.12.2008, p. 42, ELI: http://data.europa.eu/eli/dec/2008/911/oj). . (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.

Article 2

This Decision is addressed to the Member States. Done at Brussels, 13 February 2026. For the Commission Olivér Várhelyi Member of the Commission

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, плодLT (lietuvių kalba): Kartieji pankolių, vaisiaiCS (čeština): Plod fenyklu obecného pravéhoLV (latviešu valoda): Rūgtā fenheļa, augļiDA (dansk): Fennikel bitterMT (malti): Bużbież morr, frottaDE (Deutsch): Bitterer FenchelNL (nederlands): Bittere venkel, vruchtEL (elliniká): Πικρού μάραθου καρπόςPL (polski): Koper włoski odmiany gorzkiej, owocEN (English): Bitter FennelPT (português): Funcho-amargo, frutoES (español): Hinojo amargo, frutoRO (română): Fenicul amar, fructET (eesti keel): Mõru apteegitill, viliSK (slovenčina): Plod fenikla horkéhoFI (suomi): Karvasfenkoli, hedelmäSL (slovenščina): Plod grenkega navadnega komarčkaFR (français): Fenouil amer, fruitSV (svenska): Bitterfänkål, fröHR (hrvatski): Komorač gorki, plodIS (íslenska): Bitur fennel aldinHU (magyar): Keserű édeskömény, termésNO (norsk): Bitter fennikelIT (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, плодLT (lietuvių kalba): Saldieji pankolių, vaisiaiCS (čeština): Plod fenyklu obecného sladkéhoLV (latviešu valoda): Saldā fenheļa, augļiDA (dansk): Fennikel sødMT (malti): Bużbież ħelu, frottaDE (Deutsch): Süßer FenchelNL (nederlands): Zoete venkel, vruchtEL (elliniká): Γλυκού μάραθου καρπόςPL (polski): Koper włoski odmiany słodkiej, owocEN (English): Sweet fennel, fruitPT (português): Funcho-doce, frutoES (español): Hinojo dulce, frutoRO (română): Fenicul dulce, fructET (eesti keel): Magus apteegitill, viliSK (slovenčina): Plod fenikla sladkéhoFI (suomi): Makeafenkoli, hedelmäSL (slovenščina): Plod sladkega navadnega komarčkaFR (français): Fenouil doux, fruitSV (svenska): Sötfänkål, fröHR (hrvatski): Komorač slatki, plodIS (íslenska): Sæt fennel aldinHU (magyar): Édeskömény termésNO (norsk): Søt fennikelIT (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..