HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 319/102
EN
Official Journal of the European Union
2.12.2011
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)
THE EUROPEAN COMMISSION,
(3) Decision
2008/911/EC
should
therefore
be
amended
accordingly.
Having regard to the Treaty on European Union and the Treaty
on the Functioning of the European Union,
(4) The
measures
provided
for
in
this
Decision
are
in
accordance with the opinion of the Standing
Having regard to Directive 2001/83/EC of the European
Committee on Medicinal Products for Human Use,
Parliament and of the Council of 6 November 2001 on the
Community code relating to medicinal products for human
use (
HAS ADOPTED THIS DECISION:

1 ), and in particular Article 16f thereof,
Having regard to the opinion of the European Medicines
Article 1
Agency, formulated on 15 July 2010 by the Committee for
Herbal Medicinal Products,
Annexes I and II of Decision 2008/911/EC are amended in
accordance with the Annex to this Decision.
Whereas:
Article 2
(1) Hamamelis
virginiana L. can be considered as a herbal
substance, a herbal preparation or a combination
This Decision is addressed to the Member States.
thereof within the meaning of Directive 2001/83/EC
and complies with the requirements set out in that
Directive.
Done at Brussels, 28 November 2011.
(2) It
is
therefore
appropriate
to
include Hamamelis virginiana
L. in the list of herbal substances, preparations and
For the Commission
combinations thereof for use in traditional herbal
medicinal products established by Commission Decision
John DALLI
2008/911/EC ( 2 ).
Member of the Commission
( 1 ) OJ L 311, 28.11.2001, p. 67.
( 2 ) OJ L 328, 6.12.2008, p. 42.

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EN
2.12.2011 Official
Journal
of
the
European
Union L
319/103
ANNEX
Annexes I and II to Decision 2008/911/EC are amended as follows:
1. in Annex I, the following substance is inserted after Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung
(sweet fennel fruit):
‘Hamamelis virginiana L., folium et cortex aut ramunculus destillatum’;
2. in Annex II, the following is inserted after the entry relating to Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller)
Thellung, fructus:
‘COMMUNITY LIST ENTRY ON HAMAMELIS VIRGINIANA L., FOLIUM ET CORTEX AUT RAMUNCULUS
DESTILLATUM
Scientific name of the plant
Hamamelis virginiana L.
Botanical family
Hamamelidaceae
Herbal preparation(s)
1. Distillate prepared from fresh leaves and bark (1:1.12 – 2.08; extraction solvent ethanol 6 % m/m)
2. Distillate prepared from dried twigs (1:2; extraction solvent ethanol 14-15 %) (*)
European pharmacopoeia monograph reference
Not applicable
Indication(s)
Indication (a)
Traditional herbal medicinal product for relief of minor skin inflammation and dryness of the skin.
Indication (b)
Traditional herbal medicinal product to be used for the temporary relief of eye discomfort due to dryness of the eye or
to exposure to wind or sun.
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
Children over six years of age, adolescents, adults and elderly
Indication (a)
Distillate in a strength corresponding to 5-30 % in semi-solid preparations, several times daily.
The use in children under six years of age is not recommended (see section ‘Special warnings and precautions for use’).

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Official Journal of the European Union
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Adolescents, adults and elderly
Indication (b)
Eye drops (**) Distillate (2) diluted (1:10), 2 drops/each eye, 3-6 times daily.
The use in children under 12 years of age is not recommended (see section ‘Special warnings and precautions for use’).
Route of administration
Cutaneous use.
Ocular use.
Duration of use or any restrictions on the duration of use
Children over six years of age, adolescents, adults and elderly
Indication (a)
If the symptoms persist longer than two weeks during the use of the medicinal product, a doctor or a qualified
healthcare practitioner should be consulted.
Adolescents, adults and elderly
Indication (b)
The recommended duration of use is four days. If the symptoms persist longer than two days during the use of the
medicinal product, a doctor or a qualified healthcare practitioner should be consulted.
Any other information necessary for the safe use
Contraindications
Hypersensitivity to the active substance.
Special warnings and precautions for use
Indication (a)
The use in children under six years of age has not been established due to lack of adequate data.
Indication (b)
If eye pain, changes in vision, continued redness, or irritation of the eye is experienced, or if the condition worsens or
persists for more than 48 hours during the use of the medicinal product, a doctor or a qualified healthcare practitioner
should be consulted.
The use in children under 12 years of age has not been established due to lack of adequate data.
For extracts containing ethanol, the appropriate labelling for ethanol, taken from the ‘Guideline on excipients in the
label and package leaflet of medicinal products for human use’, must be included.
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
No studies on the effect on the ability to drive and use machines have been performed.
Undesirable effects
Indication (a)
Allergic contact dermatitis may occur in sensitive patients. The frequency is not known.

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Indication (b)
Conjunctivitis cases have been reported. The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare 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.
___________
(*) According to USP (USP-31- NF 26, 2008 Vol 3:3526).
(**) The medicinal product complies with the Ph. Eur. monograph on eye preparations (01/2008:1163).’.

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