{
  "url": "https://openlegislation.uk/eu-decision-2010-180/annex",
  "json_url": "https://openlegislation.uk/eu-decision-2010-180/annex.json",
  "legislation": "eudn/2010/180",
  "legislation_title": "Commission Decision of 25 March 2010 on 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(2010) 1867) (Text with EEA relevance) (2010/180/EU)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2010-180",
  "path": "annex",
  "kind": "annex",
  "number": null,
  "heading": null,
  "text": "Annexes I and II to Decision 2008/911/EC are amended as follows:\n1.. in Annex I, the following substance is inserted after Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung (sweet fennel fruit):\n‘ Mentha x piperita L.’;\n2.. in Annex II, the following is inserted after the entry relating to Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung, fructus:\n‘ COMMUNITY LIST ENTRY ON MENTHA x PIPERITA L., AETHEROLEUM\nScientific name of the plant\nMentha x piperita L.\nBotanical family\nLamiaceae (Labiatae)\nHerbal preparation(s)\nPeppermint oil essential oil obtained by steam distillation from the fresh aerial parts of the flowering plant\nEuropean Pharmacopoeia monograph reference\nPeppermint oil — Menthae piperitae aetheroleum (01/2008:0405)\nIndication(s)\nHerbal medicinal product traditionally used:\n1.. for the relief of symptoms in coughs and colds;\n2.. for the symptomatic relief of localised muscle pain;\n3.. for the symptomatic relief of localised pruritic conditions in intact skin.\nThe product is a traditional herbal medicinal product for use in specified indications exclusively based upon long-standing use.\nType of tradition\nEuropean\nSpecified strength\nIndications 1, 2 and 3\nSingle dose\nChildren between 4 to 10 years of age\nSemi-solid preparations 2-10 %\nHydroethanolic preparations 2-4 %\nChildren between 10 to 12 years of age, adolescents between 12 to 16 years of age\nSemi-solid preparations 5-15 %\nHydroethanolic preparations 3-6 %\nAdolescents over 16 years of age, adults\nSemi-solid and oily preparations 5-20 %\nIn aqueous-ethanol preparations 5-10 %\nIn nasal ointments 1-5 % essential oil.\nSpecified posology\nUp to three times daily\nThe use in children under 2 years of age is contraindicated (see “Contraindications”).\nThe use is not recommended in children between 2 to 4 years of age (see “Special warnings and precautions for use”).\nRoute of administration\nCutaneous and transdermal.\nDuration of use or any restrictions on the duration of use\nIndication 1\nNot to be used for more than 2 weeks.\nIndications 2 and 3\nIt is not recommended to use the medicinal product continuously for more than 3 months.\nIf the symptoms persist during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.\nAny other information necessary for the safe use\nContraindications\nChildren under 2 years of age, because menthol can induce reflex apnoea and laryngospasm.\nChildren with history of seizures (febrile or not).\nHypersensitivity to peppermint oil or menthol.\nSpecial warnings and precautions for use\nEye contact with unwashed hands after the application of peppermint oil may potentially cause irritation.\nPeppermint oil should not be applied on broken or irritated skin.\nThe use is not recommended in children between 2 to 4 years of age, as there is no sufficient experience available.\nInteractions with other medicinal products and other forms of interaction\nNone reported.\nPregnancy and lactation\nIn the absence of sufficient data, the use during pregnancy and lactation is not recommended.\nEffects on ability to drive and use machines\nNo studies on the effect on the ability to drive and use machines have been performed.\nUndesirable effects\nHypersensitivity 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.\nIrritation of the skin and mucosa of the nose is possible, after local application. The frequency is not known.\nIf other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.\nOverdose\nNo case of overdose has been reported.’",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2010/180/annex",
    "retrieved_at": "2026-11-01T15:16:09.340025+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}