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.

Done at Brussels, 21 November 2008.

For the Commission

Günter Verheugen

Vice-President

[1] OJ L 311, 28.11.2001, p. 67.

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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

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

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

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ANNEX II

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 (b?lgarski): Горчиво резене, плод

CS (?e?tina): Plod fenyklu obecného pravého

DA (dansk): Fennikel, bitter

DE (Deutsch): Bitterer Fenchel

EL (elliniká): Μαραθ?σπορο? πικρ??

EN (English): Bitter fennel, fruit

ES (espa?ol): Hinojo amargo, fruto de

ET (eesti keel): M?ru apteegitill, vili

FI (suomi): Karvasfenkoli, hedelm?

FR (fran?ais): Fruit de fenouil amer

HU (magyar): Keser?édesk?mény-termés

IT (italiano): Finocchio amaro (o selvatico), frutto

LT (lietuvi? kalba): Kar?i?j? pankoli? vaisiai

LV (latvie?u valoda): Rūgtā fenhe?a aug?i

MT (malti): Bu?bie? morr, frotta

NL (nederlands): Venkelvrucht, bitter

PL (polski): Owoc kopru w?oskiego (odmiana gorzka)

PT (português): Fruto de funcho amargo

RO (rom?n?): Fruct de fenicul amar

SK (sloven?ina): Feniklov? plod hork?

SL (sloven??ina): Plod grenkega navadnega komar?ka

SV (svenska): Bitterf?nk?l, frukt

IS (íslenska): Bitur fennel aldin

NO (norsk): Fenikkel, bitter

Herbal preparation(s)

Fennel, bitter, dried comminuted [1] 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 [2]) 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 (b?lgarski): Сладко резене, плод

CS (?e?tina): Plod fenyklu obecného sladkého

DA (dansk): Fennikel, s?d

DE (Deutsch): Sü?er Fenchel

EL (elliniká): Μαραθ?σπορο? γλυκ??

EN (English): Sweet fennel, fruit

ES (espa?ol): Hinojo dulce, fruto de

ET (eesti keel): Magus apteegitill, vili

FI (suomi): Makea fenkoli, hedelm?

FR (fran?ais): Fruit de fenouil doux

HU (magyar): ?desk?ménytermés

IT (italiano): Finocchio dolce (o romano), frutto

LT (lietuvi? kalba): Sald?i?j? pankoli? vaisiai

LV (latvie?u valoda): Saldā fenhe?a aug?i

MT (malti): Bu?bie? ?elu, frotta

NL (nederlands): Venkelvrucht, zoet

PL (polski): Owoc kopru w?oskiego (odmiana s?odka)

PT (português): Fruto de funcho doce

RO (rom?n?): Fruct de fenicul dulce

SK (sloven?ina): Feniklov? plod sladk?

SL (sloven??ina): Plod sladkega navadnega komar?ka

SV (svenska): S?tf?nk?l, frukt

IS (íslenska): S?t fennel aldin

NO (norsk): Fenikkel, s?t

Herbal preparation(s)

Fennel, sweet, dried comminuted [3] 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 [4]) 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.

[1] "Comminuted fruit" is intended to cover also "crushed fruit".

[2] For commercial preparation of comminuted fennel fruits the applicant must carry out appropriate stability testing related to the content of essential oil components.

[3] "Comminuted fruit" is intended to cover also "crushed fruit".

[4] 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.

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