Decision 2008/911/EC is amended as follows:
1.
Articles 1 and 2 are replaced by the following:
‘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.’.
2.
Annexes I and II are amended in accordance with the Annex to this Decision.
This Decision is addressed to the Member States.
ANNEXSupplementary provisions
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):
‘
Mentha x piperita L.’;
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 MENTHA x PIPERITA L., AETHEROLEUM
Scientific name of the plant
Mentha x piperita L.
Botanical family
Lamiaceae (Labiatae)
Herbal preparation(s)
Peppermint oil : essential oil obtained by steam distillation from the fresh aerial parts of the flowering plant
European Pharmacopoeia monograph reference
Peppermint oil — Menthae piperitae aetheroleum (01/2008:0405)
Indication(s)
Herbal medicinal product traditionally used:
1.
for the relief of symptoms in coughs and colds;
2.
for the symptomatic relief of localised muscle pain;
3.
for the symptomatic relief of localised pruritic conditions in intact skin.
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
Indications 1, 2 and 3
Single dose
Children between 4 to 10 years of age
Semi-solid preparations 2-10 %
Hydroethanolic preparations 2-4 %
Children between 10 to 12 years of age, adolescents between 12 to 16 years of age
Semi-solid preparations 5-15 %
Hydroethanolic preparations 3-6 %
Adolescents over 16 years of age, adults
Semi-solid and oily preparations 5-20 %
In aqueous-ethanol preparations 5-10 %
In nasal ointments 1-5 % essential oil.
Specified posology
Up to three times daily
The use in children under 2 years of age is contraindicated (see “Contraindications”).
The use is not recommended in children between 2 to 4 years of age (see “Special warnings and precautions for use”).
Route of administration
Cutaneous and transdermal.
Duration of use or any restrictions on the duration of use
Indication 1
Not to be used for more than 2 weeks.
Indications 2 and 3
It is not recommended to use the medicinal product continuously for more than 3 months.
If the symptoms persist 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
Children under 2 years of age, because menthol can induce reflex apnoea and laryngospasm.
Children with history of seizures (febrile or not).
Hypersensitivity to peppermint oil or menthol.
Special warnings and precautions for use
Eye contact with unwashed hands after the application of peppermint oil may potentially cause irritation.
Peppermint oil should not be applied on broken or irritated skin.
The use is not recommended in children between 2 to 4 years of age, as there is no sufficient experience available.
Interactions with other medicinal products and other forms of interaction
None reported.
Pregnancy and lactation
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 such as skin rash, contact dermatitis, and eye irritation have been reported. These reactions are most of the time mild and transient. The frequency is not known.
Irritation of the skin and mucosa of the nose is possible, after local application. 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.’
