
Article 1 
Decision 2008/911/EC is amended as follows:

1.. Annex I is amended in accordance with Annex I to this Decision.
2.. Annex II is amended in accordance with Annex II to this Decision.
Article 2 
This Decision is addressed to the Member States.
Done at Brussels, 28 July 2009.
For the Commission
Günter VERHEUGEN
Vice-President
ANNEX I

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).

ANNEX II

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)
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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
 A. Liquid extract (DER 1:1), extraction solvent ethanol 40-50 % (v/v).
 B. Liquid extract (DER 1:1,8-2,2), extraction solvent ethanol 40-50 % (v/v).
 C. Tincture (DER 1:5), extraction solvent ethanol 70-90 % (v/v).

Calendula flower – Calendulae flos (01/2005:1297)
 (a) Traditional herbal medicinal product for the symptomatic treatment of minor inflammations of the skin (such as sunburn) and as an aid in healing of minor wounds.
 (b) Traditional herbal medicinal product for the symptomatic treatment of minor inflammations in the mouth or the throat.

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:


A.. Liquid extract (DER 1:1)
In semi-solid dosage forms: amount equivalent to 2-10 % herbal substance.
B.. Liquid extract (DER 1:1,8-2,2)
In semi-solid dosage forms: amount equivalent to 2-5 % herbal substance.
C.. 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.
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— ‘Pimpinella anisum L’ is inserted after Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung (Sweet fennel, fruit)
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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)
 (a) Traditional herbal medicinal product for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence.
 (b) 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

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) 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.
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