
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
ANNEX I


 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. 
Foeniculum vulgare Miller subsp. vulgare var. vulgare

Apiaceae

Fennel, bitter


 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

Fennel, bitter, dried comminuted fruit.

Foeniculi amari fructus (01/2005:0824).


((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.

European, Chinese.

Please see ‘Specified posology’.

Single dose

1,5 to 2,5 g of (freshly) comminuted fennel fruits with 0,25 l of boiling water (brew for 15 minutes) three times daily as a herbal tea.

Adult dose

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’).

Oral use.

Not to be taken for more than two weeks.

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.

Hypersensitivity to the active substance or to Apiaceae (Umbelliferae) (aniseed, caraway, celery, coriander and dill) or to anethole.

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.

None reported.

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.

No studies on the effect on the ability to drive and use machines have been performed.

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.

No case of overdose has been reported.

Not applicable.

Not applicable.

B. 
Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung

Apiaceae

Fennel, sweet


 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

Fennel, sweet, dried comminuted or powdered fruit.

Foeniculi dulcis fructus (01/2005:0825).


((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.

European, Chinese.

Please see ‘Specified posology’.

Single dose

1,5 to 2,5 g of (freshly) 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).

Adult dose

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’).

Oral use.

Not to be taken for more than two weeks.

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.

Hypersensitivity to the active substance or to Apiaceae (Umbelliferae) (aniseed, caraway, celery, coriander and dill) or to anethole.

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.

None reported.

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.

No studies on the effect on the ability to drive and use machines have been performed.

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.

No case of overdose has been reported.

Not applicable.

Not applicable.
