2008/911/EC: 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)
Date: 2008-11-21
Institutions: European Commission
Subjects: alternative medicine, crop production, medical plant, medicinal product

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Official Journal of the European Union

6.12.2008

COMMISSION

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,

(3)

The measures provided for
accordance with
Committee on Medicinal Products for Human Use,

in this Decision are in
Standing
the

opinion

the

of

HAS ADOPTED THIS DECISION:

Article 1

A list of herbal substances, preparations and combinations
thereof for use in traditional herbal medicinal products is estab­
lished 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
for
the safe use as a traditional medicinal product relevant
and
Foeniculum vulgare Miller
(Miller)
Foeniculum vulgare Miller
Thellung are set out in Annex II to this decision.

vulgare
vulgare var. dulce

subsp.
subsp.

vulgare

var.

This Decision is addressed to the Member States.

Article 3

Done at Brussels, 21 November 2008.

For the Commission

Günter VERHEUGEN
Vice-President

Having regard to the Treaty
Community,

establishing the European

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)

(2)

Foeniculum vulgare Miller subsp. vulgare var. vulgare and
Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller)
Thellung comply with the requirements
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 combi­
nations thereof.

set out

It is therefore appropriate to establish a list of herbal
for
substances, preparations and combinations thereof
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.

(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 (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

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

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

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’.

(1) ‘Comminuted fruit’ is intended to cover also ‘crushed fruit’.

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Specified posology

Adults

Single dose

1,5 to 2,5 g of (freshly (1)) 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,
symptoms only (less than one week).

in three divided doses, for short-term use in mild transitory

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.

(1) For commercial preparation of comminuted fennel fruits the applicant must carry out appropriate stability testing related to the content

of essential oil components.

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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 (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

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

FR (français): Fruit de fenouil doux

SV (svenska): Sötfänkål, frukt

HU (magyar): Édesköménytermés

IS (íslenska): Sæt fennel aldin

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

NO (norsk): Fenikkel, søt

Herbal preparation(s)

Fennel, sweet, dried comminuted (1) 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.

(1) ‘Comminuted fruit’ is intended to cover also ‘crushed fruit’.

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(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 (1)) 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,
symptoms only (less than one week).

in three divided doses, for short-term use in mild transitory

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.

(1) 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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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.