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)
Grade B
mapped from publisher markup. A grade says how a document's structure was obtained, not how reliable the law is.
Address https://gelex.eu/eli/EU/decision/2008/911@2008-11-21/en
Contents
- Preamble
- ANNEX
- ANNEX II A.
- Scientific name of the plant
- Botanical family
- Herbal substance
- Herbal preparation(s)
- European Pharmacopoeia monograph reference
- Indication(s)
- Type of tradition
- Specified strength
- Specified posology Adults
- Route of administration
- Duration of use or any restrictions on the duration of use Adults
- Any other information necessary for the safe use Contraindications
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, 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
ANNEX
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.
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
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
Herbal preparation(s)
Fennel, bitter, dried comminuted fruit.
European Pharmacopoeia monograph reference
Foeniculi amari fructus (01/2005:0824).
Indication(s)
The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.
(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.
Type of tradition
European, Chinese.
Specified strength
Please see Specified posology.
Specified posology Adults
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.
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
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
Herbal preparation(s)
Fennel, sweet, dried comminuted or powdered fruit.
European Pharmacopoeia monograph reference
Foeniculi dulcis fructus (01/2005:0825).
Indication(s)
The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.
(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.
Type of tradition
European, Chinese.
Specified strength
Please see Specified posology.
Specified posology Adults
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).
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.
Versions
Cited by
- Commission Decision of 9 December 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2009) 9703) (Text with EEA relevance) (2010/30/EU) Decision · Grade B
It is therefore appropriate to include Eleutherococcus senticosus (Rupr. et Maxim.) Maxim and Echinacea purpurea (L.) Moench in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established in Annex I to Commission Decision 2008/911/EC.
- Commission Decision of 9 December 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2009) 9703) (Text with EEA relevance) (2010/30/EU) Decision · Grade B
Decision 2008/911/EC should therefore be amended accordingly.
- Commission Decision of 9 December 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2009) 9703) (Text with EEA relevance) (2010/30/EU) Decision · Grade B
Decision 2008/911/EC is amended as follows:
- Commission Decision of 9 December 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2009) 9703) (Text with EEA relevance) (2010/30/EU) Decision · Grade B
In Annex I to Decision 2008/911/EC, the following two substances are inserted after Calendula officinalis L.:
- Commission Decision of 9 December 2009 amending the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2009) 9703) (Text with EEA relevance) (2010/30/EU) Decision · Grade B
In Annex II to Decision 2008/911/EC, the following is inserted after the entry relating to Calendula officinalis L:
- Commission Implementing Decision (EU) 2016/1658 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5747) (Text with EEA relevance) Decision · Grade B
In 2008 an opinion of the European Medicines Agency established that Eleutherococcus senticosus (Rupr. et Maxim) Maxim complied with the requirements set out in Directive 2001/83/EC as a herbal substance, a herbal preparation or a combination thereof within the meaning of that Directive and it was 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 Implementing Decision (EU) 2016/1658 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5747) (Text with EEA relevance) Decision · Grade B
Decision 2008/911/EC should therefore be amended accordingly.
- Commission Implementing Decision (EU) 2016/1658 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5747) (Text with EEA relevance) Decision · Grade B
Annex II to Decision 2008/911/EC is amended in accordance with the Annex to this Decision.
- Commission Implementing Decision (EU) 2016/1658 of 13 September 2016 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2016) 5747) (Text with EEA relevance) Decision · Grade B
In Annex II to Decision 2008/911/EC, the entry Eleutherococcus Senticosus (Rupr. et Maxim) Maxim., Radix is amended as follows:
- Commission Implementing Decision of 28 November 2011 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2011) 7382) (Text with EEA relevance) (2011/785/EU) Decision · Grade B
It is therefore appropriate to include Hamamelis virginiana L. 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 Implementing Decision of 28 November 2011 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2011) 7382) (Text with EEA relevance) (2011/785/EU) Decision · Grade B
Decision 2008/911/EC should therefore be amended accordingly.
- Commission Implementing Decision of 28 November 2011 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2011) 7382) (Text with EEA relevance) (2011/785/EU) Decision · Grade B
Annexes I and II of Decision 2008/911/EC are amended in accordance with the Annex to this Decision.
- Commission Implementing Decision of 28 November 2011 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2011) 7382) (Text with EEA relevance) (2011/785/EU) Decision · Grade B
Annexes I and II to Decision 2008/911/EC are amended as follows:
- Commission Decision of 25 March 2010 on amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2010) 1867) (Text with EEA relevance) (2010/180/EU) Decision · Grade B
It is therefore appropriate to include Mentha x piperita L. 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 of 25 March 2010 on amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2010) 1867) (Text with EEA relevance) (2010/180/EU) Decision · Grade B
Decision 2008/911/EC should therefore be amended accordingly.
- Commission Decision of 25 March 2010 on amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2010) 1867) (Text with EEA relevance) (2010/180/EU) Decision · Grade B
Decision 2008/911/EC is amended as follows:
- Commission Decision of 25 March 2010 on amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2010) 1867) (Text with EEA relevance) (2010/180/EU) Decision · Grade B
Annexes I and II to Decision 2008/911/EC are amended as follows:
- Council Decision (EU) 2026/1535 of 25 June 2026 on the position to be adopted on behalf of the European Union within the Joint Committee established by the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco concerning amendments to the Annex to that Agreement Decision · Grade B
Commission Decision 2010/180/EU of 25 March 2010 on amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (OJ L 80, 26.3.2010, p. 52);
- Council Decision (EU) 2026/1535 of 25 June 2026 on the position to be adopted on behalf of the European Union within the Joint Committee established by the Agreement between the European Community and the Principality of Monaco on the application of certain Community acts on the territory of the Principality of Monaco concerning amendments to the Annex to that Agreement Decision · Grade B
MEDICINES 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), as amended by: Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1), as amended by: Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018
- Commission Implementing Decision of 3 February 2012 amending Decision 2008/911/EC establishing a list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products (notified under document C(2012) 514) (Text with EEA relevance) (2012/67/EU) Decision · Grade B
It is therefore appropriate to include Thymus vulgaris L., Thymus zygis Loefl. ex L. in the list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products established by Commission Decision 2008/911/EC.