Annex

Annexes I and II to Decision 2008/911/EC are amended as follows:

1. 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. 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. 1..

      for the relief of symptoms in coughs and colds;

   2. 2..

      for the symptomatic relief of localised muscle pain;

   3. 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.’