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)

• Published date: 06 December 2008
• Official Gazette Publication: Journal officiel de l’Union européenne, L 328, 06 décembre 2008,Diario Oficial de la Unión Europea, L 328, 06 de diciembre de 2008,Gazzetta ufficiale dell’Unione europea, L 328, 06 dicembre 2008

02008D0911 — EN — 26.01.2018 — 006.001

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►B 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) (OJ L 328 6.12.2008, p. 42)

Amended by:

		Official Journal
		No	page	date
►M1	COMMISSION DECISION 2010/28/EC of 28 July 2009	L 11	12	16.1.2010
►M2	COMMISSION DECISION 2010/30/EU of 9 December 2009	L 12	14	19.1.2010
►M3	COMMISSION DECISION 2010/180/EU of 25 March 2010	L 80	52	26.3.2010
►M4	COMMISSION IMPLEMENTING DECISION 2011/785/EU of 28 November 2011	L 319	102	2.12.2011
►M5	COMMISSION IMPLEMENTING DECISION 2012/67/EU of 3 February 2012	L 34	5	7.2.2012
►M6	COMMISSION IMPLEMENTING DECISION 2012/68/EU of 3 February 2012	L 34	8	7.2.2012
►M7	COMMISSION IMPLEMENTING DECISION (EU) 2016/1658 Text with EEA relevance of 13 September 2016	L 247	19	15.9.2016
►M8	COMMISSION IMPLEMENTING DECISION (EU) 2016/1659 Text with EEA relevance of 13 September 2016	L 247	22	15.9.2016
►M9	COMMISSION IMPLEMENTING DECISION (EU) 2018/133 Text with EEA relevance of 24 January 2018	L 22	36	26.1.2018
►M10	COMMISSION IMPLEMENTING DECISION (EU) 2018/134 Text with EEA relevance of 24 January 2018	L 22	41	26.1.2018

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▼B

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)

▼M3

Article 1

A list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products is established in Annex I.

Article 2

The indications, the specified strengths and the posology, the route of administration and any other information necessary for the safe use of the herbal substance as a traditional medicinal product relevant for the herbal substances listed in Annex I are set out in Annex II.

▼B

Article 3

This Decision is addressed to the Member States.

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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

▼M1

Calendula officinalis L

▼M2

Echinacea purpurea (L.) Moench

Eleutherococcus senticosus (Rupr. et Maxim.) Maxim

▼B

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

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

▼M4

Hamamelis virginiana L., folium et cortex aut ramunculus destillatum

▼M8

Melaleuca alternifolia (Maiden and Betch) Cheel, M. linariifolia Smith, M. dissitiflora F. Mueller and/or other species of Melaleuca, aetheroleum

▼M3

Mentha x piperita L.

▼M1

Pimpinella anisum L

▼M10

Sideritis scardica Griseb., herba.

▼M5

Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum

▼M9

Valeriana officinalis L.

▼M6

Vitis vinifera L., folium

▼B

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ANNEX II

▼M1

COMMUNITY LIST ENTRY ON CALENDULA OFFICINALIS L

Scientific name of the plant

Calendula officinalis L.

Botanical family

Asteraceae

Herbal substance

Calendula flower

Common name in all EU official languages of herbal substance

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

Herbal preparation(s)

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).

European Pharmacopoeia monograph reference

Calendula flower – Calendulae flos (01/2005:1297)

Indication(s)

(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.

Type of tradition

European

Specified strength

Please see ‘Specified posology’.

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’).

Route of administration

Cutaneous and oromucosal use.

Duration of use or any restrictions on the duration of 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.

Any other information necessary for the safe use

Contraindications

Hypersensitivity to members of the Asteraceae (Compositae) family.

Special warnings and precautions for use

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.

Interactions with other medicinal products and other forms of interaction

None reported.

Pregnancy and lactation

Safety during pregnancy and lactation has not been established.

In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Effects on ability to drive and use machines

Not relevant.

Undesirable effects

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.

Overdose

None reported.

▼M2

COMMUNITY LIST ENTRY ON ECHINACEA PURPUREA (L.) MOENCH, HERBA RECENS

Scientific name of the plant

Echinacea purpurea (L.) Moench

Botanical family

Asteraceae

Herbal substance

Purple coneflower herb

Common name in all EU official languages of herbal substance

BG (bălgarski): пурпурна ехинацея, пресен стрък

CS (čeština): čerstvá nať třapatky nachové

DA (dansk): Purpursolhat, frisk urt

DE (Deutsch): Purpursonnenhutkraut, frisch

EL (elliniká): Πόα Εχινάκεας της πορφυράς

EN (English): purple coneflower herb

ES (español): Equinácea purpúrea, partes aéreas incluidas sumidades floridas

ET (eesti keel): punane siilkübar

FI (suomi): kaunopunahattu, tuore verso

FR (français): parties aériennes fraîches d’échinacée pourpre

HU (magyar): bíbor kasvirág virágos hajtása

IT (italiano): Echinacea purpurea, pianta fresca

LT (lietuvių kalba): rausvažiedžių ežiuolių žolė

LV (latviešu valoda): purpursarkanās ehinacejas laksti

MT (malti): Echinacea Vjola

NL (nederlands): rood zonnehoedkruid

PL (polski): jeżówka purpurowa, świeże ziele

PT (português): Equinácea, partes aéreas floridas

RO (română): iarbã proaspãtã de Echinacea, pãlãria soarelui

SK (slovenčina): echinacea purpurová, čerstvá vňať

SL (slovenščina): sveža zel škrlatne ehinaceje

SV (svenska): röd solhatt, färsk ört

IS (íslenska): Sólhattur

NO (norsk): Rød solhatt

Herbal preparation(s)

Expressed juice and dried expressed juice from fresh flowering aerial parts.

European Pharmacopoeia monograph reference

N/A

Indication(s)

Traditional herbal medicinal product for treatment of small superficial wounds.

The product is a traditional herbal medicinal product for use in a specified indication exclusively based on long-standing use.

Type of tradition

European.

Specified strength

10 to 20 g/100 g of...