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7.2.2012 Official
Journal
of
the
European
Union L
34/5
DECISIONS
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)
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
Having regard to Directive 2001/83/EC of the European
accordance with the opinion of the Standing
Parliament and of the Council of 6 November 2001 on the
Committee on Medicinal Products for Human Use,
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
Annexes I and II to Decision 2008/911/EC are amended in
Herbal Medicinal Products,
accordance with the Annex to this Decision.
Whereas:
Article 2
(1) Thymus
vulgaris L., Thymus zygis Loefl. ex L. can be
This Decision is addressed to the Member States.
considered as a herbal substance, a herbal preparation
or a combination thereof within the meaning of
Directive 2001/83/EC and it complies with the
requirements set out in that Directive.
Done at Brussels, 3 February 2012.
(2) It
is
therefore
appropriate
to
include Thymus vulgaris L.,
Thymus zygis Loefl. ex L. in the list of herbal substances,
For the Commission
preparations and combinations thereof for use in tradi
tional herbal medicinal products established by
John DALLI
Commission Decision 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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L 34/6
EN
Official Journal of the European Union
7.2.2012
ANNEX
Decision 2008/911/EC is amended as follows:
(1) in Annex I, the following substance is inserted after Pimpinella anisum L.:
‘Thymus vulgaris L., Thymus zygis Loefl. ex L., aetheroleum’;
(2) in Annex II, the following is inserted after the entry on Pimpinella anisum L.:
‘COMMUNITY LIST ENTRY ON THYMUS VULGARIS L., THYMUS ZYGIS LOEFL. EX L., AETHEROLEUM
Scientific name of the plant
Thymus vulgaris L., Thymus zygis Loefl. ex L.
Botanical family
Lamiaceae
Herbal preparation(s)
Essential oil obtained by steam distillation from the fresh flowering aerial parts of Thymus vulgaris L., Thymus zygis
Loefl. ex L. or a mixture of both species
European Pharmacopoeia monograph reference
01/2008:1374
Indication(s)
Traditional herbal medicinal product for the relief of symptoms in coughs and colds.
The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-
standing use.
Type of tradition
European
Specified strength
Please see “Specified posology”
Specified posology
Adults and elderly
Cutaneous use: in liquid and semi-solid dosage forms in concentrations up to 10 %; apply up to 3 times daily.
Use as bath additive: 0,007-0,025 g per litre.
Adolescents
Use as bath additive: 0,007-0,025 g per litre
Children 6-12 years
Use as bath additive: 0,0035-0,017 g per litre
Children 3-6 years
Use as bath additive: 0,0017-0,0082 g per litre
One bath every day or every second day.
The cutaneous use in children and adolescents under 18 years of age is not recommended (see section “Special
warnings and precaution for use”).
The use as bath additive in children under 3 years of age is not recommended (see section “Special warnings and
precaution for use”).
Route of administration
Cutaneous use: apply to the chest and the back.
Use as a bath additive: recommended temperature of bath: 35-38 °C.

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EN
7.2.2012 Official
Journal
of
the
European
Union L
34/7
Duration of use or any restrictions on the duration of use
Duration of a bath: 10-20 minutes.
If the symptoms persist longer than 1 week, 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.
Use as bath additive:
Full baths are contraindicated in cases of open wounds, large skin injuries, acute skin diseases, high fever, severe
infections, severe circulatory disturbances and cardiac insufficiency.
Special warnings and precautions for use
Cutaneous use:
Like other essential oils Thyme oil should not be applied to the face particularly in the nasal area of babies and infants
under the age of 2 years because of the risk of a laryngospasm.
When dyspnoea, fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted.
The use in children and adolescents under 18 years of age is not recommended due to lack of adequate data.
Use as bath additive:
When dyspnoea, fever or purulent sputum occurs, a doctor or a qualified health care practitioner should be consulted.
The use in children under 3 years of age is not recommended because medical advice should be sought and due to
lack of adequate data.
In cases of hypertension, a full bath should be used with caution.
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
Hypersensitivity reactions and skin irritation have been observed. 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.’

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