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 10 January 2008 and 6 March 2008 by the Committee for Herbal Medicinal Products,
Whereas:
(1) Calendula officinalis L and Pimpinella anisum L comply with the requirements set out in Directive 2001/83/EC. Calendula officinalis L and Pimpinella anisum L can be considered as herbal substances, herbal preparations or combinations thereof.
(2) It is therefore appropriate to include Calendula officinalis L and Pimpinella anisum L 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(2).
(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:
Decision 2008/911/EC is amended as follows:
Annex I is amended in accordance with Annex I to this Decision.
Annex II is amended in accordance with Annex II to this Decision.
This Decision is addressed to the Member States.
Done at Brussels, 28 July 2009.
For the Commission
Günter Verheugen
Vice-President
In Annex I to Decision 2008/911/EC, the following is inserted:
‘Calendula officinalis L’ is inserted before Foeniculum vulgare Miller subsp. vulgare var. vulgare (Bitter fennel, fruit),
‘Pimpinella anisum L’ is inserted after Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung (Sweet fennel, fruit).
In Annex II to Decision 2008/911/EC, the following is inserted:
‘Calendula officinalis L’ is inserted before Foeniculum vulgare Miller subsp. vulgare var. vulgare (Bitter fennel, fruit)
Calendula officinalis L.
Asteraceae
Calendula flower
BG (bălgarski): Невен, цвят
CS (čeština): Měsíčkový květ
DA (dansk): Morgenfrueblomst
DE (Deutsch): Ringelblumenblüten
EL (elliniká): Άνθος καλέντουλας
EN (English): Calendula flower
ES (español): Flor de caléndula
ET (eesti keel): Saialilleõisik
FI (suomi): Tarhakehäkukan kukka
FR (français): Souci
HU (magyar): A körömvirág virága
IT (italiano): Calendula fiore
LT (lietuvių kalba): Medetkų žiedai
LV (latviešu valoda): Kliņģerītes ziedi
MT (malti): Fjura calendula
NL (nederlands): Goudsbloem
PL (polski): Kwiat nagietka
PT (português): Flor de calêndula
RO (română): Floare de gălbenele (calendula)
SK (slovenčina): Nechtíkový kvet
SL (slovenščina): Cvet vrtnega ognjiča
SV (svenska): Ringblomma, blomma
IS (íslenska): Morgunfrú, blóm
NO (norsk): Ringblomst
Calendula flower – Calendulae flos (01/2005:1297)
The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.
European
Please see “Specified posology”.
Herbal preparations:
Liquid extract (DER 1:1)
In semi-solid dosage forms: amount equivalent to 2-10 % herbal substance.
Liquid extract (DER 1:1,8-2,2)
In semi-solid dosage forms: amount equivalent to 2-5 % herbal substance.
Tincture (DER 1:5)
In compresses diluted at least 1:3 with freshly boiled water.
In semi-solid dosage forms: amount equivalent to 2-10 % herbal substance.
As a gargle or mouth rinse in a 2 % solution.
2 to 4 times daily
Indication (a)
The use is not recommended in children under 6 years of age (see below “Special warnings and precautions for use”).
Indication (b)
The use in children under 12 years of age is not recommended because there is no experience available (see below “Special warnings and precautions for use”).
Cutaneous and oromucosal use.
Compresses: remove after 30-60 minutes
All herbal preparations: If the symptoms persist after 1 week during the use of the medicinal product a doctor or a qualified health care practitioner should be consulted.
Hypersensitivity to members of the Asteraceae (Compositae) family.
Indication (a)
The use in children under 6 years of age is not recommended because there is no experience available.
Indication (b)
The use in children under 12 years of age is not recommended because there is no experience available.
If signs of skin infection are observed, a doctor or a qualified health care practitioner should be consulted.
None reported.
Safety during pregnancy and lactation has not been established.
In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
Not relevant.
Skin sensitisation. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.
None reported.’
‘Pimpinella anisum L’ is inserted after Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung (Sweet fennel, fruit)
Pimpinella anisum L.
Apiaceae
Aniseed
BG (bălgarski): Анасон, плод
CS (čeština): Anýzový plod
DA (dansk): Anisfrø
DE (Deutsch): Anis
EL (elliniká): Γλυκάνισο
EN (English): Aniseed
ES (español): Fruto de anís
ET (eesti keel): Aniis
FI (suomi): Anis
FR (français): Anis (fruit d)
HU (magyar): Ánizsmag
IT (italiano): Anice (Anice verde), frutto
LT (lietuvių kalba): Anyžių sėklos
LV (latviešu valoda): Anīsa sēklas
MT (malti): Frotta tal-Anisi
NL (nederlands): Anijsvrucht
PL (polski): Owoc anyżu
PT (português): Anis
RO (română): Fruct de anason
SK (slovenčina): Anízový plod
SL (slovenščina): Plod vrtnega janeža
SV (svenska): Anis
IS (íslenska): Anís
NO (norsk): Anis
Dried aniseed, comminuted or crushed
Anisi fructus (01/2005:0262)
The product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.
European
Please see “Specified posology”
Adolescents over 12 years of age, adults, elderly:
Indications (a) and (b)
1 to 3,5 g of whole or (freshly(3)) comminuted or crushed aniseed in 150 ml of boiling water as a herbal tea
3 times daily
The use in children under 12 years is not recommended of age (see below “Special warnings and precautions for use”).
Oral use
Not to be taken for more than 2 weeks.
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) (caraway, celery, coriander, dill and fennel) or to anethole.
The use is not recommended in children under 12 years of age due to the lack of adequate data for safety assessment.
None reported.
There are no data from the use of aniseed in pregnant patients.
It is unknown if aniseed 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 aniseed 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.’
For commercial preparations of comminuted or crushed aniseed the applicant must carry out appropriate stability testing related to the content of essential oil components.’